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Regulatory Approval Program for Sleep Study Sensors with Embedded Wireless Links
- Small Business Information
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Advanced Medical Electronics Corp.6901 East Fish Lake Road Suite #190 Maple Grove, MN 55369-View profile »Woman-Owned: NoMinority-Owned: NoHUBZone-Owned: No
- Phase 2
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Fiscal Year: 2007Title: Regulatory Approval Program for Sleep Study Sensors with Embedded Wireless LinksAgency: HHSContract: 2R44MH062251-04Award Amount: $511,733.00
Abstract:
DESCRIPTION (provided by applicant): This competing continuation SBIR application proposes to complete a regulatory approvals program on a set of next-generation sleep disorder monitoring sensors. Advanced Medical Electronics (AME) completed in June of 200 5 a phase II NIMH SBIR developing sleep sensors with embedded wireless links. AME completed on this phase II program the development of a set of production prototype wireless sleep sensors and created a polysomnograph recording and analysis software packag e for use with the developed sensors. This application seeks funding to perform FDA required regulatory approvals testing for the developed wire- less polysomnograph sensors and the associated software package. FDA approval is required prior to the commerc ial sale of the device.Small Business Information at Submission:ADVANCED MEDICAL ELECTRONICS CORPORATION
6901 EAST FISH LAKE ROAD SUITE #190 MAPLE GROVE, MN 55369EIN/Tax ID: 411693828DUNS: N/ANumber of Employees: N/AWoman-Owned: NoMinority-Owned: NoHUBZone-Owned: No
Award Information
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Agency: Department of Health and Human Services |
Branch: N/A |
Award ID: 61111 |
Program Year/Program: 2007 / SBIR |
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Agency Tracking Number: MH062251 |
Solicitation Year: N/A |
Solicitation Topic Code: N/A |
Solicitation Number: N/A |