The following data is part of a premarket notification filed by Colin Medical Instruments Corp. with the FDA for Colin's Model Apbm-630 And Quinton's Model 470.
| Device ID | K872355 |
| 510k Number | K872355 |
| Device Name: | COLIN'S MODEL APBM-630 AND QUINTON'S MODEL 470 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | COLIN MEDICAL INSTRUMENTS CORP. 1330 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
| Contact | Edward M Lebow |
| Correspondent | Edward M Lebow COLIN MEDICAL INSTRUMENTS CORP. 1330 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-18 |
| Decision Date | 1987-09-15 |