The following data is part of a premarket notification filed by Electro-biology, Inc. with the FDA for Arthroscope.
| Device ID | K971083 |
| 510k Number | K971083 |
| Device Name: | ARTHROSCOPE |
| Classification | Arthroscope |
| Applicant | ELECTRO-BIOLOGY, INC. 6 UPPER POND RD. P.O. BOX 345 Parsippany, NJ 07054 |
| Contact | Jon Caparotta |
| Correspondent | Jon Caparotta ELECTRO-BIOLOGY, INC. 6 UPPER POND RD. P.O. BOX 345 Parsippany, NJ 07054 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-25 |
| Decision Date | 1997-06-23 |
| Summary: | summary |