The following data is part of a premarket notification filed by Protek Medical Products, Inc. with the FDA for Ultrasound Systems Drape.
| Device ID | K970885 |
| 510k Number | K970885 |
| Device Name: | ULTRASOUND SYSTEMS DRAPE |
| Classification | Cover, Barrier, Protective |
| Applicant | PROTEK MEDICAL PRODUCTS, INC. 221 E. MARKET ST. SUITE 291 Iowa City, IA 52245 |
| Contact | Rick L Pruter |
| Correspondent | Rick L Pruter PROTEK MEDICAL PRODUCTS, INC. 221 E. MARKET ST. SUITE 291 Iowa City, IA 52245 |
| Product Code | MMP |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-11 |
| Decision Date | 1997-09-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841912100682 | K970885 | 000 |
| 20841912104257 | K970885 | 000 |
| 10841912106063 | K970885 | 000 |
| 10841912106056 | K970885 | 000 |
| 10841912106711 | K970885 | 000 |
| 10841912104250 | K970885 | 000 |
| 10841912106254 | K970885 | 000 |
| 10841912100542 | K970885 | 000 |
| 10841912100535 | K970885 | 000 |
| 00841912100521 | K970885 | 000 |
| 00841912100514 | K970885 | 000 |
| 30841912104254 | K970885 | 000 |
| 10841912100559 | K970885 | 000 |
| 10841912100641 | K970885 | 000 |
| 10841912105332 | K970885 | 000 |
| 10841912105028 | K970885 | 000 |
| 10841912104960 | K970885 | 000 |
| 00841912104567 | K970885 | 000 |
| 10841912104410 | K970885 | 000 |
| 00841912104086 | K970885 | 000 |
| 10841912100863 | K970885 | 000 |
| 10841912100672 | K970885 | 000 |
| 10841912100665 | K970885 | 000 |
| 10841912100658 | K970885 | 000 |
| 10841912100504 | K970885 | 000 |