The following data is part of a premarket notification filed by Geistlich-pharma with the FDA for Sonar-aid(r) Ultrasound Standoff Pad.
| Device ID | K874943 |
| 510k Number | K874943 |
| Device Name: | SONAR-AID(R) ULTRASOUND STANDOFF PAD |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | GEISTLICH-PHARMA 1050 CONNECTICUT AVE. N.W. Washington, DC 20036 |
| Contact | Peter S Reichertz |
| Correspondent | Peter S Reichertz GEISTLICH-PHARMA 1050 CONNECTICUT AVE. N.W. Washington, DC 20036 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-02 |
| Decision Date | 1988-07-25 |