DG PORTABLE SYSTEM
FDA 510(k) clearance K954157 · decided 1996-01-17
Clearance details
- K-number
- K954157
- Device name
- DG PORTABLE SYSTEM
- Applicant
- Medelec , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1995-09-05
- Decision date
- 1996-01-17
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- OLT
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Old Woking, Surrey, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.