FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES
K Number: K905288
·
Decision Apr 9, 1991
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
54
Applicant Total
3
Review Days
134
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Basic Information
- Device Name
- ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES
- K Number
- K905288
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5580
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Med-Tek Innovations, Inc.
- Date Received
- November 26, 1990
- Decision Date
- April 9, 1991
- Product Code
- BYG
- 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 |
|---|---|---|---|
| BYG | Mask, Oxygen | FDA class 1 | Anesthesiology |
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