FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TEMPERATURE CONTROLLER MODEL 17000
K Number: K781530
·
Decision Nov 14, 1978
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
45
Applicant Total
35
Review Days
69
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Basic Information
- Device Name
- TEMPERATURE CONTROLLER MODEL 17000
- K Number
- K781530
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5270
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Healthdyne, Inc.
- Date Received
- September 6, 1978
- Decision Date
- November 14, 1978
- Product Code
- BZE
- 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 |
|---|---|---|---|
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZE), ordered by most recent decision date.
inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidification Chamber (VHC10); inspired Auto-feed Humidification Chamber (VHC20)
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Other Clearances by Healthdyne, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K950331 | PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS) | Sep 21, 1995 | Substantially Equivalent |
| K922106 | ALICE | Jul 6, 1994 | Substantially Equivalent |
| K942357 | H-500 ALLIANCE OXYGEN CONCENTRATOR | May 27, 1994 | Substantially Equivalent |
| K934502 | FLOW SPIROMETER | Apr 4, 1994 | Substantially Equivalent |
| K924146 | OH-500 OXYGEN CONCENTRATOR | Jan 7, 1993 | Substantially Equivalent |
| K922623 | NEBULIZER SYSTEM | Dec 1, 1992 | Substantially Equivalent |
| K910118 | DATA RECORDER | Feb 14, 1991 | Substantially Equivalent |
| K903287 | MODEL 900S APNEA/HEART MONITOR | Aug 17, 1990 | Substantially Equivalent |
| K894030 | MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR | Jan 22, 1990 | Substantially Equivalent |
| K892006 | HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S | May 23, 1989 | Substantially Equivalent |