510(k) K093126
K093126 is an FDA 510(k) premarket notification submitted by Hospitech Respiration , Ltd. for the device "ANAPNOGUARD ENDOTRACHEAL TUBE". The FDA issued a decision of Substantially Equivalent on March 2, 2010. The device falls under product code BTP (Dropper, Ether), a Class I device regulated under 21 CFR 868.5420. Hospitech Respiration , Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 2010
- Date Received
- October 2, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dropper, Ether
- Device Class
- Class I
- Regulation Number
- 868.5420
- Review Panel
- AN
- Submission Type