The following data is part of a premarket notification filed by Sentech Medical Corp. with the FDA for Porta Gas Compressed Gas Cylinder Cart.
| Device ID | K910071 |
| 510k Number | K910071 |
| Device Name: | PORTA GAS COMPRESSED GAS CYLINDER CART |
| Classification | Motor, Surgical Instrument, Pneumatic Powered |
| Applicant | SENTECH MEDICAL CORP. 1963 ROCK ST. SUITE 17 Mountain View, CA 94043 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose SENTECH MEDICAL CORP. 1963 ROCK ST. SUITE 17 Mountain View, CA 94043 |
| Product Code | GET |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-09 |
| Decision Date | 1991-03-22 |