RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT
FDA 510(k) clearance K072736 · decided 2008-01-22
Clearance details
- K-number
- K072736
- Device name
- RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT
- Applicant
- Rhythmlink International, LLC
- Decision
- Substantially Equivalent
- Date received
- 2007-09-27
- Decision date
- 2008-01-22
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- ETN
- Device class
- 2
- Regulation number
- 874.1820
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Columbia, SC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink Monopol recall (Z-1960-2015) | Spine Wave, Inc. | 2015-07-02 |