FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PEDIATRIC ANESTHESIA CIRCUIT
K Number: K770549
·
Decision Mar 30, 1977
Classifications
1
FEI Numbers
201
Registration Numbers
201
Same Product Code
183
Applicant Total
20
Review Days
9
Basic Information
- Device Name
- PEDIATRIC ANESTHESIA CIRCUIT
- K Number
- K770549
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5240
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- INSPIRON CORP.
- Date Received
- March 21, 1977
- Decision Date
- March 30, 1977
- 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 |
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|---|---|---|---|
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| K840935 | MANUAL RESUSCITATION SYSTEM | Apr 5, 1984 | Substantially Equivalent |
| K841158 | NEBULO 28 NEBULIZER KIT | Mar 30, 1984 | Substantially Equivalent |
| K840418 | INSPIRATORY/EXPIRATORY MUSCLE EXERCIS | Feb 17, 1984 | Substantially Equivalent |
| K834290 | INSPIRON LIQUID OXYGEN SYSTEM | Feb 4, 1984 | Substantially Equivalent |
| K772069 | VOL. VENTILATOR SETUP W/OUT NEBULIZER | Nov 15, 1977 | Substantially Equivalent |
| K772070 | VENTILATOR SETUP, VOLUME | Nov 15, 1977 | Substantially Equivalent |
| K772071 | MANIFOLD & NEBU. FOR SINGLE LINE MACH. | Nov 15, 1977 | Substantially Equivalent |