ANAPNOGUARD ENDOTRACHEAL TUBE
FDA 510(k) clearance K093126 · decided 2010-03-02
Clearance details
- K-number
- K093126
- Device name
- ANAPNOGUARD ENDOTRACHEAL TUBE
- Applicant
- Hospitech Respiration , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-10-02
- Decision date
- 2010-03-02
- Days to decision
- 151 days
- Clearance type
- Traditional
- Product code
- BTP
- Device class
- 1
- Regulation number
- 868.5420
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Binyamina, IL
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Hospitech Respiration
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.