The following data is part of a premarket notification filed by Human Performance Technologies, Inc. with the FDA for 2p-qda Foot Pressure Systems Real Time.
Device ID | K882139 |
510k Number | K882139 |
Device Name: | 2P-QDA FOOT PRESSURE SYSTEMS REAL TIME |
Classification | System, Pressure Measurement, Intermittent |
Applicant | HUMAN PERFORMANCE TECHNOLOGIES, INC. 12 TECHNOLOGY DRIVE, SUITE 6 East Setauket, NY 11733 |
Contact | Michael Witover |
Correspondent | Michael Witover HUMAN PERFORMANCE TECHNOLOGIES, INC. 12 TECHNOLOGY DRIVE, SUITE 6 East Setauket, NY 11733 |
Product Code | JFC |
CFR Regulation Number | 890.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-23 |
Decision Date | 1988-06-22 |