Ultrasound Transmission Gel
FDA 510(k) K905545 · Arbo Medical, Inc.
510(k) numberK905545
Submission
- Device name
- Ultrasound Transmission Gel
- Applicant
- Arbo Medical, Inc.
Stratford, CT, US - Received
- December 11, 1990
- Decision date
- March 29, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JOT – Electrode, Gel, Electrosurgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code JOT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K923647 | Rfg-Dgp Disposable Grounding PadsJOT · Traditional | Radionics, Inc. | 11/09/1992SE |
| K904418 | Ultrasound Coupling GelJOT · Traditional | Geno Laboratories | 02/11/1991SE |
| K901217 | Tria-Sonic Ultra Sound Transmission GelJOT · Traditional | H & P Industries, Inc. | 06/22/1990SE |
| K894490 | Sterile Ultrasound Transmission GelJOT · Traditional | Swedish Trade Council USA | 10/05/1989SE |
| K884503 | Ultrasonic Transmission GelJOT · Traditional | Herbert Stanley Co. | 02/13/1989SE |
| K872519 | Sterilized Omni GelJOT · Traditional | Echo Ultrasound | 08/03/1987SE |
| K871565 | Ultrasound Transducer Gel, SterileJOT · Traditional | Amedic USA | 07/15/1987SE |
| K800933 | R2 Electrosurg. Return Elect. #225ETC.JOT · Traditional | R2 Corp. | 05/20/1980SE |
More from R2 Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K940323 | Arbo Diagnostic ECG Patient Cables & Leadwires Arbo Shielded Multi-Lead Cable & Lead…DSA · Traditional | 04/12/1995SE |
| K935437 | Arbo H85V/H87V/H27V Dispos Monit ElectrodesDRX · Traditional | 04/06/1995SE |
| K942905 | Disposable Temperature Probe CoverFMT · Traditional | 02/27/1995SE |
| K940302 | Arbo Monitring Safety Cable & Lead Wire Systems/Arbo Unsheilded Safety Cable & Lead SystemDSA · Traditional | 11/30/1994SE |
| K940322 | Arbo VS Monitor Cable & Leadwire System Arbo Shielded Safety Cable & Lead WireDSA · Traditional | 11/28/1994SE |
| K935246 | Arbo H49P, H59P Disposable Monitoring ElectrodesDRX · Traditional | 11/16/1994SE |
| K935429 | Arbo H90, H91, H135 Disposable Monitoring ElectrodesDRX · Traditional | 11/01/1994SE |
| K935281 | Arbo H87P, H85P, H27P Disposable Monitoring ElectrodesDRX · Traditional | 09/06/1994SE |
| K902788 | Clem TMFIB · Traditional | 09/12/1990SE |
| K901816 | Pressure Tubing and AccessoriesCAH · Traditional | 07/12/1990SE |
Questions and answers
When was Ultrasound Transmission Gel cleared by the FDA?
Ultrasound Transmission Gel (K905545) received a 510(k) decision of Substantially Equivalent on March 29, 1991, 108 days after the submission was received.
What is the product code of K905545?
The FDA product code is JOT – Electrode, Gel, Electrosurgical, a Class II (moderate risk) device regulated under 21 CFR 878.4400.