FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
AG GUFFILL
K Number: K122721
·
Decision May 3, 2013
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
38
Applicant Total
6
Review Days
240
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Basic Information
- Device Name
- AG GUFFILL
- K Number
- K122721
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5750
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hospitech Respiration , Ltd.
- Date Received
- September 5, 2012
- Decision Date
- May 3, 2013
- Product Code
- BSK
- 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 |
|---|---|---|---|
| BSK | Cuff, Tracheal Tube, Inflatable | FDA class 2 | Anesthesiology |
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Cuffix
FDA 510(k)
FDA Class 2
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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 |
| K093126 | ANAPNOGUARD ENDOTRACHEAL TUBE | Mar 2, 2010 | Substantially Equivalent |