FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CONCHAPAK OXYGEN DILUTER
K Number: K780011
·
Decision Feb 2, 1978
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
18
Applicant Total
26
Review Days
30
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Basic Information
- Device Name
- CONCHAPAK OXYGEN DILUTER
- K Number
- K780011
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5600
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Respiratory Care, Inc.
- Date Received
- January 3, 1978
- Decision Date
- February 2, 1978
- Product Code
- BYF
- 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 |
|---|---|---|---|
| BYF | Mask, Oxygen, Low Concentration, Venturi | FDA class 1 | Anesthesiology |
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OXY-DIAL
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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 |