VAPOR-PHASE HEATED WIRE CONTROLLER
FDA 510(k) clearance K881137 · decided 1988-04-27
Clearance details
- K-number
- K881137
- Device name
- VAPOR-PHASE HEATED WIRE CONTROLLER
- Applicant
- Advanced Research Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-03-16
- Decision date
- 1988-04-27
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- BZE
- Device class
- 2
- Regulation number
- 868.5270
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Corinth, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.