The following data is part of a premarket notification filed by International Medical Products, Inc. with the FDA for Digital Cuff Pv Gauge.
| Device ID | K900755 |
| 510k Number | K900755 |
| Device Name: | DIGITAL CUFF PV GAUGE |
| Classification | Cuff, Tracheal Tube, Inflatable |
| Applicant | INTERNATIONAL MEDICAL PRODUCTS, INC. P.O. BOX 5162 6821 SUTHERLAND COURT Mentor, OH 44060 |
| Contact | Nayan S Shah |
| Correspondent | Nayan S Shah INTERNATIONAL MEDICAL PRODUCTS, INC. P.O. BOX 5162 6821 SUTHERLAND COURT Mentor, OH 44060 |
| Product Code | BSK |
| CFR Regulation Number | 868.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-16 |
| Decision Date | 1990-04-26 |