FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT
K Number: K941547
·
Decision Mar 1, 1995
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
26
Review Days
336
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Basic Information
- Device Name
- CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT
- K Number
- K941547
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5710
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Allied Healthcare Products, Inc.
- Date Received
- March 30, 1994
- Decision Date
- March 1, 1995
- Product Code
- BYK
- 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 |
|---|---|---|---|
| BYK | Tent, Oxygen, Electrically Powered | FDA class 2 | Anesthesiology |
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