FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SEALFLEX MASK
K Number: K874746
·
Decision Dec 21, 1987
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
50
Applicant Total
22
Review Days
33
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Basic Information
- Device Name
- SEALFLEX MASK
- K Number
- K874746
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5550
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Engineered Medical Systems
- Date Received
- November 18, 1987
- Decision Date
- December 21, 1987
- 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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