The following data is part of a premarket notification filed by U.s. Medical Corp. with the FDA for Auto-cuff(tm).
| Device ID | K896633 |
| 510k Number | K896633 |
| Device Name: | AUTO-CUFF(TM) |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | U.S. MEDICAL CORP. 408 HIGHLAND AVENLUE P.O. BOX 580 Cheshire, CT 06410 |
| Contact | Bruce E Dodson |
| Correspondent | Bruce E Dodson U.S. MEDICAL CORP. 408 HIGHLAND AVENLUE P.O. BOX 580 Cheshire, CT 06410 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-22 |
| Decision Date | 1990-02-01 |