The following data is part of a premarket notification filed by Advantage Medical Systems, Inc. with the FDA for Ultrasound Transucer, Model Us915 -- Modification.
| Device ID | K923335 |
| 510k Number | K923335 |
| Device Name: | ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION |
| Classification | Transducer, Ultrasonic, Obstetric |
| Applicant | ADVANTAGE MEDICAL SYSTEMS, INC. 925 SHERMAN AVE. Hamden, CT 06514 |
| Contact | Solomita, Jr |
| Correspondent | Solomita, Jr ADVANTAGE MEDICAL SYSTEMS, INC. 925 SHERMAN AVE. Hamden, CT 06514 |
| Product Code | HGL |
| CFR Regulation Number | 884.2960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-08 |
| Decision Date | 1994-07-22 |