FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55
FDA 510(k) clearance K072002 · decided 2008-01-31
Clearance details
- K-number
- K072002
- Device name
- FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55
- Applicant
- Draeger Medical AG & Co. KG
- Decision
- Substantially Equivalent
- Date received
- 2007-07-23
- Decision date
- 2008-01-31
- Days to decision
- 192 days
- Clearance type
- Traditional
- Product code
- CAH
- Device class
- 2
- Regulation number
- 868.5260
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Telford, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.