FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESPIRATORY INTENSIVE CARE SYSTEM (RICS)
K Number: K810927
·
Decision Apr 14, 1981
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
304
Applicant Total
26
Review Days
8
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Basic Information
- Device Name
- RESPIRATORY INTENSIVE CARE SYSTEM (RICS)
- K Number
- K810927
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1400
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Allied Healthcare Products, Inc.
- Date Received
- April 6, 1981
- Decision Date
- April 14, 1981
- Product Code
- CCK
- 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 |
|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | FDA class 2 | Anesthesiology |
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Other Clearances by Allied Healthcare Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K131098 | EMERGENCY PORTABLE VENTILATOR | Apr 9, 2014 | Substantially Equivalent |
| K132021 | AHP 300, EMERGENCY PORTABLE VENTILATOR | Apr 2, 2014 | Substantially Equivalent |
| K090356 | EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 | May 20, 2009 | Substantially Equivalent |
| K083507 | BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS | May 18, 2009 | Substantially Equivalent |
| K083385 | MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B | May 14, 2009 | Substantially Equivalent |
| K080063 | MASS CASUALTY VENTILATOR, MODEL MCV100 | Aug 15, 2008 | Substantially Equivalent |
| K072214 | PORTABLE VENTILATOR, MODEL EPV-100 | Mar 6, 2008 | Substantially Equivalent |
| K073171 | RESUSCITATION TIMER, MODEL L770-CPR | Jan 31, 2008 | Substantially Equivalent |
| K070636 | AUTOVENT 4000 WITH CPAP | Jul 13, 2007 | Substantially Equivalent |
| K070120 | AUTOVENT MODEL 4000 | May 3, 2007 | Substantially Equivalent |