FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MASK, ANESTH. INFLATABLE & PEDIATRIC SCENTED, DISP
K Number: K880682
·
Decision Mar 21, 1988
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
50
Applicant Total
18
Review Days
31
Basic Information
- Device Name
- MASK, ANESTH. INFLATABLE & PEDIATRIC SCENTED, DISP
- K Number
- K880682
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5550
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- KING SYSTEMS CORP.
- Date Received
- February 19, 1988
- Decision Date
- March 21, 1988
- 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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