FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
AG100s
K Number: K221477
·
Decision Dec 29, 2022
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
38
Applicant Total
6
Review Days
220
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AG100s
- K Number
- K221477
- 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
- May 23, 2022
- Decision Date
- December 29, 2022
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BSK), ordered by most recent decision date.
CuffGuard
FDA 510(k)
FDA Class 2
·Anesthesiology
CuffTrek
FDA 510(k)
FDA Class 2
·Anesthesiology
TrachCuff Cuff Controller
FDA 510(k)
FDA Class 2
·Anesthesiology
Puritan Bennett Cuff Pressure Manager
FDA 510(k)
FDA Class 2
·Anesthesiology
Cuffix
FDA 510(k)
FDA Class 2
·Anesthesiology
Pylant Monitor
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Hospitech Respiration , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K093126 | ANAPNOGUARD ENDOTRACHEAL TUBE | Mar 2, 2010 | Substantially Equivalent |