FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POSITIVE AIRWAY PRESSURE SYSTEM
K Number: K933184
·
Decision Nov 28, 1994
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
459
Applicant Total
22
Review Days
516
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Basic Information
- Device Name
- POSITIVE AIRWAY PRESSURE SYSTEM
- K Number
- K933184
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Innovative Medical Systems, Inc.
- Date Received
- June 30, 1993
- Decision Date
- November 28, 1994
- Product Code
- BZD
- 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 |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | FDA class 2 | Anesthesiology |
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| K915456 | PHACO 3000 LINEAR | Feb 12, 1992 | Substantially Equivalent |
| K883599 | LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) | Sep 2, 1988 | Substantially Equivalent |
| K880745 | LX-100 SLIDE STAINER | Apr 27, 1988 | Substantially Equivalent |
| K853938 | LX 300 TISSUE PROCESSOR | Oct 10, 1985 | Substantially Equivalent |