The following data is part of a premarket notification filed by Protocol Systems, Inc. with the FDA for Propaq 102, 104 And 106.
Device ID | K910772 |
510k Number | K910772 |
Device Name: | PROPAQ 102, 104 AND 106 |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | PROTOCOL SYSTEMS, INC. 14924 N.W. GREENBRIER PKWY. Beaverton, OR 97006 |
Contact | James W Sandberg |
Correspondent | James W Sandberg PROTOCOL SYSTEMS, INC. 14924 N.W. GREENBRIER PKWY. Beaverton, OR 97006 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-22 |
Decision Date | 1991-04-12 |