EBICE
FDA 510(k) clearance K945067 · decided 1995-02-09
Clearance details
- K-number
- K945067
- Device name
- EBICE
- Applicant
- Electro-Biology, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1994-10-14
- Decision date
- 1995-02-09
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- ILO
- Device class
- 2
- Regulation number
- 890.5720
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Parsippany, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.