FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AIRMED PNEUMATIC EQUIP. FILTRA/CONTROL
K Number: K820079
·
Decision Feb 5, 1982
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
73
Applicant Total
5
Review Days
24
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Basic Information
- Device Name
- AIRMED PNEUMATIC EQUIP. FILTRA/CONTROL
- K Number
- K820079
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.6250
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- James L. Geraci & Associates, Inc.
- Date Received
- January 12, 1982
- Decision Date
- February 5, 1982
- Product Code
- BTI
- 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 |
|---|---|---|---|
| BTI | Compressor, Air, Portable | FDA class 2 | Anesthesiology |
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Other Clearances by James L. Geraci & Associates, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K853927 | LASE SYSTEM II | Oct 16, 1985 | Substantially Equivalent |
| K820091 | AIRMED SMOKE EVACUATION & FILTER | Feb 24, 1982 | Substantially Equivalent |
| K820078 | DRAPE, SURGICAL | Feb 4, 1982 | Substantially Equivalent |
| K811698 | CARL ZEISS INN MYRINGOTOMY TUBE LINE | Aug 31, 1981 | Substantially Equivalent |