HYGEIA-5 OXYGEN CONCENTRATOR
FDA 510(k) clearance K081267 · decided 2008-09-23
Clearance details
- K-number
- K081267
- Device name
- HYGEIA-5 OXYGEN CONCENTRATOR
- Applicant
- Kedl Internation Limited
- Decision
- Substantially Equivalent
- Date received
- 2008-05-05
- Decision date
- 2008-09-23
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Fort Myers, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.