FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDIVAC
K Number: K924577
·
Decision Mar 23, 1993
Classifications
1
FEI Numbers
193
Registration Numbers
193
Same Product Code
86
Applicant Total
5
Review Days
194
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Basic Information
- Device Name
- MEDIVAC
- K Number
- K924577
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medisonic U.S.A., Inc.
- Date Received
- September 10, 1992
- Decision Date
- March 23, 1993
- Product Code
- GCX
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | FDA class 2 | General Hospital |
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Other Clearances by Medisonic U.S.A., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923660 | MEDISONIC OXYGEN FLOW CONTROLLER | Jan 27, 1993 | Substantially Equivalent |
| K901114 | MEDISONIC HUMDIFIER/INHALER | May 22, 1990 | Substantially Equivalent |
| K896192 | MEDISONIC PNEU-NEB | Jan 3, 1990 | Substantially Equivalent |
| K894961 | MEDISONIC ULTRA-SONIC INHALER | Nov 24, 1989 | Substantially Equivalent |