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Regulatory Approval Program for Sleep Study Sensors with Embedded Wireless Links

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
61111
Program Year/Program:
2007 / SBIR
Agency Tracking Number:
MH062251
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
ADVANCED MEDICAL ELECTRONICS CORPORATION
6901 E FISH LAKE RD, STE 190 MAPLE GROVE, MN -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2007
Title: Regulatory Approval Program for Sleep Study Sensors with Embedded Wireless Links
Agency: HHS
Contract: 2R44MH062251-04
Award 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.

Principal Investigator:

Kevin M. Kramer
7634634814
KKRAMER@AME-CORP.COM

Business Contact:

Tom Hendrickson
7634634814
THENDRICKSON@AME-CORP.COM
Small Business Information at Submission:

ADVANCED MEDICAL ELECTRONICS CORPORATION
6901 EAST FISH LAKE ROAD SUITE #190 MAPLE GROVE, MN 55369

EIN/Tax ID: 411693828
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No