FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANESTHESIA BREATHING CIRCUIT
K Number: K851193
·
Decision Jun 14, 1985
Classifications
1
FEI Numbers
199
Registration Numbers
199
Same Product Code
183
Applicant Total
5
Review Days
80
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
- ANESTHESIA BREATHING CIRCUIT
- K Number
- K851193
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5240
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Avatron, Inc.
- Date Received
- March 26, 1985
- Decision Date
- June 14, 1985
- Product Code
- CAI
- 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 |
|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAI), ordered by most recent decision date.
CONDENSATE COLLECTION KIT
FDA 510(k)
FDA Class 1
·Anesthesiology
UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT
FDA 510(k)
FDA Class 1
·Anesthesiology
UNICOR, INC. GAS SAMPLING LINES & CONNECTORS
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA COAXIAL CIRCUITS
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA ADULT GAS SAMPLING CIRCUITS
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA PEDIATRIC ANESTHESIA CIRCUITS
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Avatron, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K844956 | AVA-MIST PORTABLE AIR COMPRESSOR | Feb 14, 1985 | Substantially Equivalent |
| K843102 | AVA-NEB NEBULIZER | Aug 17, 1984 | Substantially Equivalent |
| K842778 | AVATRON UNIVERSAL ADULT VOL. VENTILATOR | Jul 26, 1984 | Substantially Equivalent |
| K842389 | AVATRON DISPOSABLE I.P.P.B. CIRUCIT | Jun 26, 1984 | Substantially Equivalent |