The following data is part of a premarket notification filed by Directed Energy, Inc. with the FDA for Ortho. Gas Insufflator Model In-2 For Arthro. Surg.
| Device ID | K873331 |
| 510k Number | K873331 |
| Device Name: | ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURG |
| Classification | Arthroscope |
| Applicant | DIRECTED ENERGY, INC. 11661 SAN VICENTE BLVD. SUITE 203 Los Angeles, CA 90049 |
| Contact | Edward Johansen |
| Correspondent | Edward Johansen DIRECTED ENERGY, INC. 11661 SAN VICENTE BLVD. SUITE 203 Los Angeles, CA 90049 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-19 |
| Decision Date | 1988-02-17 |