FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SLIMB SINGLE LIMB BREATHING CIRCUIT
K Number: K832453
·
Decision Oct 27, 1983
Classifications
1
FEI Numbers
199
Registration Numbers
199
Same Product Code
183
Applicant Total
26
Review Days
93
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Basic Information
- Device Name
- SLIMB SINGLE LIMB BREATHING CIRCUIT
- K Number
- K832453
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5240
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Respiratory Care, Inc.
- Date Received
- July 26, 1983
- Decision Date
- October 27, 1983
- 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
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|---|---|---|---|
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| K881625 | CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL | Jun 21, 1988 | Substantially Equivalent |
| K864147 | AQUAVALVE | Dec 5, 1986 | Substantially Equivalent |
| K863955 | COLBY LEVEL ALARM | Nov 7, 1986 | Substantially Equivalent |
| K861555 | CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT | Jun 5, 1986 | Substantially Equivalent |
| K834151 | CONCHATHERM LHF HUMIDIFIER HEATER | Jan 13, 1984 | Substantially Equivalent |
| K833974 | AQUAPAK 020 HUMIDIFIER ADAPTER | Dec 16, 1983 | Substantially Equivalent |
| K811524 | AQUACADE | Jul 1, 1981 | Substantially Equivalent |
| K811073 | A QUAPAK | Apr 29, 1981 | Substantially Equivalent |