DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570
FDA 510(k) clearance K021118 · decided 2002-05-28
Clearance details
- K-number
- K021118
- Device name
- DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570
- Applicant
- Class A Ent.
- Decision
- Substantially Equivalent
- Date received
- 2002-04-08
- Decision date
- 2002-05-28
- Days to decision
- 50 days
- Clearance type
- Special
- Product code
- GXZ
- Device class
- 2
- Regulation number
- 882.1350
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Hesperia, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.