FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SUR-FIT FACE MASK
K Number: K854161
·
Decision Nov 5, 1985
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
50
Applicant Total
1
Review Days
25
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Basic Information
- Device Name
- SUR-FIT FACE MASK
- K Number
- K854161
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5550
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Anesthesia Respiratory Technology, Inc.
- Date Received
- October 11, 1985
- Decision Date
- November 5, 1985
- Product Code
- BSJ
- 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 |
|---|---|---|---|
| BSJ | Mask, Gas, Anesthetic | FDA class 1 | Anesthesiology |
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