The following data is part of a premarket notification filed by Protocol Systems, Inc. with the FDA for Propaq 104(tm).
Device ID | K882085 |
510k Number | K882085 |
Device Name: | PROPAQ 104(TM) |
Classification | Computer, Blood-pressure |
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 | DSK |
CFR Regulation Number | 870.1110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-18 |
Decision Date | 1988-07-28 |