The following data is part of a premarket notification filed by Camino Laboratories, Inc. with the FDA for Model V420 Direct Pressure Monitor & 427 Waveform.
Device ID | K893232 |
510k Number | K893232 |
Device Name: | MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM |
Classification | Computer, Blood-pressure |
Applicant | CAMINO LABORATORIES, INC. 5955 PACIFIC CENTER BLVD. San Diego, CA 92121 |
Contact | Hazel Shumway |
Correspondent | Hazel Shumway CAMINO LABORATORIES, INC. 5955 PACIFIC CENTER BLVD. San Diego, CA 92121 |
Product Code | DSK |
CFR Regulation Number | 870.1110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-28 |
Decision Date | 1989-07-14 |