TENS
FDA 510(k) clearance K850006 · decided 1985-12-20
Clearance details
- K-number
- K850006
- Device name
- TENS
- Applicant
- Zimmer Elektromedizin GmbH
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1985-01-02
- Decision date
- 1985-12-20
- Days to decision
- 352 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- 7910 Neu-Ulm, Germany, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.