The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Model 420 System Measurement, Blood Pressure.
Device ID | K871363 |
510k Number | K871363 |
Device Name: | MODEL 420 SYSTEM MEASUREMENT, BLOOD PRESSURE |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
Contact | Randy Walls |
Correspondent | Randy Walls QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-07 |
Decision Date | 1987-06-05 |