FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONCHA-COLUMN
K Number: K760866
·
Decision Nov 1, 1976
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
220
Applicant Total
26
Review Days
14
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Basic Information
- Device Name
- CONCHA-COLUMN
- K Number
- K760866
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5450
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Respiratory Care, Inc.
- Date Received
- October 18, 1976
- Decision Date
- November 1, 1976
- Product Code
- BTT
- 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 |
|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Respiratory Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K892230 | RCI VIRAL/BACTERIAL FILTER | Aug 28, 1989 | Substantially Equivalent |
| K884150 | MODIFIED CONCHATHERM III CONTROLLED HEATER | Nov 21, 1988 | Substantially Equivalent |
| 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 |
| K832453 | SLIMB SINGLE LIMB BREATHING CIRCUIT | Oct 27, 1983 | Substantially Equivalent |
| K811524 | AQUACADE | Jul 1, 1981 | Substantially Equivalent |