The following data is part of a premarket notification filed by Arbo Medical, Inc. with the FDA for Ultrasound Transmission Gel.
| Device ID | K905545 |
| 510k Number | K905545 |
| Device Name: | ULTRASOUND TRANSMISSION GEL |
| Classification | Electrode, Gel, Electrosurgical |
| Applicant | ARBO MEDICAL, INC. 300 LONG BEACH BLVD. Stratford, CT 06497 |
| Contact | Wayne D Shockloss |
| Correspondent | Wayne D Shockloss ARBO MEDICAL, INC. 300 LONG BEACH BLVD. Stratford, CT 06497 |
| Product Code | JOT |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-11 |
| Decision Date | 1991-03-29 |