The following data is part of a premarket notification filed by Integrated Endoscopy, Inc. with the FDA for Nuvis Battery Arthroscope.
| Device ID | K191594 |
| 510k Number | K191594 |
| Device Name: | Nuvis Battery Arthroscope |
| Classification | Arthroscope |
| Applicant | Integrated Endoscopy, Inc. 16 Technology Drive, Suite 165 Irvine, CA 92618 |
| Contact | Albert Rego |
| Correspondent | Albert Rego Integrated Endoscopy, Inc. 16 Technology Drive, Suite 165 Irvine, CA 92618 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-17 |
| Decision Date | 2019-07-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10853816008008 | K191594 | 000 |
| 00853816008001 | K191594 | 000 |