FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MOBILE PAK, MODEL AC
K Number: K880261
·
Decision Feb 12, 1988
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
286
Applicant Total
2
Review Days
21
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Basic Information
- Device Name
- MOBILE PAK, MODEL AC
- K Number
- K880261
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Intl. Biomedical Concepts, Inc.
- Date Received
- January 22, 1988
- Decision Date
- February 12, 1988
- Product Code
- CAW
- 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 |
|---|---|---|---|
| CAW | Generator, Oxygen, Portable | FDA class 2 | Anesthesiology |
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Other Clearances by Intl. Biomedical Concepts, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880262 | MOBILE PAK, MODEL DC | Feb 12, 1988 | Substantially Equivalent |