The following data is part of a premarket notification filed by Colin Medical Instruments Corp. with the FDA for Bp-408 Mark Ii.
| Device ID | K884885 |
| 510k Number | K884885 |
| Device Name: | BP-408 MARK II |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | COLIN MEDICAL INSTRUMENTS CORP. 107G CORPORATE BLVD. South Plainfield, NJ 07080 |
| Contact | Alan P Schwartz |
| Correspondent | Alan P Schwartz COLIN MEDICAL INSTRUMENTS CORP. 107G CORPORATE BLVD. South Plainfield, NJ 07080 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-22 |
| Decision Date | 1989-02-23 |