The following data is part of a premarket notification filed by Integrated Endoscopy, Inc. with the FDA for Nuvis Arthroscope.
| Device ID | K140903 |
| 510k Number | K140903 |
| Device Name: | NUVIS ARTHROSCOPE |
| Classification | Arthroscope |
| Applicant | INTEGRATED ENDOSCOPY, INC. 23141 ARROYO VISTA, STE 100 Rancho Santa Margarita, CA 92688 |
| Contact | Anil Bhalani |
| Correspondent | Anil Bhalani INTEGRATED ENDOSCOPY, INC. 23141 ARROYO VISTA, STE 100 Rancho Santa Margarita, CA 92688 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-09 |
| Decision Date | 2014-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08538160080027 | K140903 | 000 |