FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDIKEEPER
K Number: K912346
·
Decision Jul 30, 1991
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
4
Applicant Total
1
Review Days
63
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Basic Information
- Device Name
- MEDIKEEPER
- K Number
- K912346
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6100
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medikeeper, Inc.
- Date Received
- May 28, 1991
- Decision Date
- July 30, 1991
- Product Code
- BRY
- 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 |
|---|---|---|---|
| BRY | Cabinet, Table And Tray, Anesthesia | FDA class 1 | Anesthesiology |
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