FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALARM, THERMAL, THERM-ALERT
K Number: K760683
·
Decision Sep 27, 1976
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
20
Applicant Total
26
Review Days
7
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Basic Information
- Device Name
- ALARM, THERMAL, THERM-ALERT
- K Number
- K760683
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Respiratory Care, Inc.
- Date Received
- September 20, 1976
- Decision Date
- September 27, 1976
- Product Code
- KPD
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KPD | Strip, Temperature, Forehead, Liquid Crystal | FDA class 2 | General Hospital |
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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 |