FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇱 Israel
ANAPNOGUARD ENDOTRACHEAL TUBE
K Number: K093126
·
Decision Mar 2, 2010
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
6
Review Days
151
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Basic Information
- Device Name
- ANAPNOGUARD ENDOTRACHEAL TUBE
- K Number
- K093126
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5420
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hospitech Respiration , Ltd.
- Date Received
- October 2, 2009
- Decision Date
- March 2, 2010
- Product Code
- BTP
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BTP | Dropper, Ether | FDA class 1 | Anesthesiology |
Other Clearances by Hospitech Respiration , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K221477 | AG100s | Dec 29, 2022 | Substantially Equivalent |
| K180991 | AG 100s | Oct 12, 2018 | Substantially Equivalent |
| K150157 | AnapnoGuard 100 Respiratory Guard System | Feb 16, 2016 | Substantially Equivalent |
| K131099 | AG MASS | May 13, 2013 | Substantially Equivalent |
| K122721 | AG GUFFILL | May 3, 2013 | Substantially Equivalent |