FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NOVA OXYGEN TENT
K Number: K893713
·
Decision Aug 21, 1989
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
10
Applicant Total
3
Review Days
95
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Basic Information
- Device Name
- NOVA OXYGEN TENT
- K Number
- K893713
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5700
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Nova Health Systems, Inc.
- Date Received
- May 18, 1989
- Decision Date
- August 21, 1989
- Product Code
- BYL
- 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 |
|---|---|---|---|
| BYL | Tent, Oxygen | FDA class 1 | Anesthesiology |
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