ELECTROMEDICS BT422-120 AND BT422-40
FDA 510(k) clearance K903392 · decided 1990-09-06
Clearance details
- K-number
- K903392
- Device name
- ELECTROMEDICS BT422-120 AND BT422-40
- Applicant
- Electromedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-07-27
- Decision date
- 1990-09-06
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- CAC
- Device class
- 2
- Regulation number
- 868.5830
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Englewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.