510(k) K070779
- Device
- SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM
- Applicant
- MISONIX, INC.
- 510(k) number
- K070779
- Product code
- NTB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-07-09
- Date received
- 2007-03-21
- Regulation
- 878.4400
- Classification name
- System, Ablation, Ultrasound And Accessories
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RONALD MANNA
- Address
- 1938 New Hwy. Farmingdale NY US 11735 11735
FDA Registration Numbers#
- 3010408671
- 1058584
- 1018470
Source Documents#
Other 510(k) Records For Product Code NTB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K150019 | TheraVision Ultrasound Ablation System and ACOUSTx Applicators | Acoustic Medsystems, Inc. | 2016-01-13 |
| K060346 | ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM | Ultrazonix Dnt AB | 2006-12-22 |
| K042096 | MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM | Misonix, Inc. | 2006-01-26 |
| K040641 | ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1 | Epicor Medical, Inc. | 2004-05-05 |
| K022894 | EPICOR MEDICAL ABLATION SYSTEM | Epicor Medical, Inc. | 2004-02-26 |
Legacy Summary#
summary
FDA Review#
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