FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PZ-800 VOLUME VENTILATOR
K Number: K822835
·
Decision Sep 29, 1983
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
504
Applicant Total
30
Review Days
373
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Basic Information
- Device Name
- PZ-800 VOLUME VENTILATOR
- K Number
- K822835
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Narco Scientific
- Date Received
- September 21, 1982
- Decision Date
- September 29, 1983
- Product Code
- CBK
- 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | FDA class 2 | Anesthesiology |
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| K Number | Device Name | ||
|---|---|---|---|
| K830338 | NARCOTRACE 80 | Dec 22, 1983 | Substantially Equivalent |
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| K831429 | AS 191 ECG TELEMETRY MODULE | Oct 14, 1983 | Substantially Equivalent |
| K831430 | AIR SHIELDS AS-100 MONIORING SYS-AS105 | Sep 12, 1983 | Substantially Equivalent |
| K831460 | AS 30/TCP MODULE | Jul 12, 1983 | Substantially Equivalent |
| K830123 | DISP. YANKAVER SURG. SUCTION INSTRUMENT | Jun 8, 1983 | Substantially Equivalent |
| K831028 | TI-1000 TRANSPORT INCUBATOR | May 9, 1983 | Substantially Equivalent |
| K823899 | INFANT CARE SYSTEM | Apr 14, 1983 | Substantially Equivalent |
| K830680 | AIR-SHIELDS VENTIMETER VENTILATOR-CONTR | Apr 8, 1983 | Substantially Equivalent |
| K830654 | INFUSION PUMP RETROGRADE EXTEN. AS 715 | Mar 24, 1983 | Substantially Equivalent |