FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST)
K Number: K911399
·
Decision Sep 19, 1991
Classifications
1
FEI Numbers
112
Registration Numbers
112
Same Product Code
7
Applicant Total
24
Review Days
174
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Basic Information
- Device Name
- NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST)
- K Number
- K911399
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.5410
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Aequitron Medical, Inc.
- Date Received
- March 29, 1991
- Decision Date
- September 19, 1991
- Product Code
- DZD
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| DZD | Tube, Orthodontic | FDA class 1 | Dental |
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