OXYGEN CONCENTRATOR, MODEL BX-5000
FDA 510(k) clearance K854374 · decided 1986-01-03
Clearance details
- K-number
- K854374
- Device name
- OXYGEN CONCENTRATOR, MODEL BX-5000
- Applicant
- Healthdyne, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-10-30
- Decision date
- 1986-01-03
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Marietta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.