RUSCH BRONCHUS BLOCKER KIT
FDA 510(k) clearance K010596 · decided 2001-11-21
Clearance details
- K-number
- K010596
- Device name
- RUSCH BRONCHUS BLOCKER KIT
- Applicant
- Rusch Intl.
- Decision
- Substantially Equivalent
- Date received
- 2001-02-28
- Decision date
- 2001-11-21
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- CBI
- Device class
- 2
- Regulation number
- 868.5740
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Jaffrey, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.