FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VACU-AIDE
K Number: K872094
·
Decision Oct 15, 1987
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
76
Applicant Total
12
Review Days
136
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Basic Information
- Device Name
- VACU-AIDE
- K Number
- K872094
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- The Devilbiss Co.
- Date Received
- June 1, 1987
- Decision Date
- October 15, 1987
- Product Code
- JCX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | FDA class 2 | General, Plastic Surgery |
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Other Clearances by The Devilbiss Co.
| K Number | Device Name | ||
|---|---|---|---|
| K874041 | DEVILBISS MODEL 8500D | Dec 23, 1987 | Substantially Equivalent |
| K872826 | ULTRA-NEB 99 ULTRASONIC NEBULIZER | Sep 4, 1987 | Substantially Equivalent |
| K872470 | DEVO/MC44 OXYGEN CONCENTRATOR | Aug 3, 1987 | Substantially Equivalent |
| K854520 | PULMO-AIDE MODEL 5610D | Dec 9, 1985 | Substantially Equivalent |
| K852209 | DEVO/MC29 OXYGEN CONCENTRATOR MC29D | Jun 24, 1985 | Substantially Equivalent |
| K851695 | ULTRA-NEB 100 ULTRASONIC NEBULIZER | Jun 5, 1985 | Substantially Equivalent |
| K830174 | DE VO/44 OXYGEN CONCENTRATOR #444 | Feb 17, 1983 | Substantially Equivalent |
| K801526 | SURVEYOR I, RESPIRATORY COMPUTER SYSTEM | Jul 21, 1980 | Substantially Equivalent |
| K792385 | DEVO OXYGEN CONCENTRATOR, MODEL 955 | Dec 5, 1979 | Substantially Equivalent |
| K781073 | PULMO-SONIC | Sep 27, 1978 | Substantially Equivalent |