The following data is part of a premarket notification filed by Colin Medical Instruments Corp. with the FDA for Colin Electronics Co., Ltd. Stbp 680.
| Device ID | K854481 |
| 510k Number | K854481 |
| Device Name: | COLIN ELECTRONICS CO., LTD. STBP 680 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | COLIN MEDICAL INSTRUMENTS CORP. 35 GERE PLACE Fanwood, NJ 07023 |
| Contact | Shinoda |
| Correspondent | Shinoda COLIN MEDICAL INSTRUMENTS CORP. 35 GERE PLACE Fanwood, NJ 07023 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-07 |
| Decision Date | 1986-06-09 |