FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPERATING ROOM VENTILATOR
K Number: K770084
·
Decision Feb 23, 1977
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
3
Applicant Total
5
Review Days
40
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Basic Information
- Device Name
- OPERATING ROOM VENTILATOR
- K Number
- K770084
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5070
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Dupaco, Inc.
- Date Received
- January 14, 1977
- Decision Date
- February 23, 1977
- Product Code
- FZH
- 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 |
|---|---|---|---|
| FZH | Apparatus, Air Handling, Room | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
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Other Clearances by Dupaco, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K150518 | Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm | Jun 29, 2015 | Substantially Equivalent |
| K841581 | UNIFILTER ANESTHESIA & RESPIRATORY FILT | Apr 30, 1984 | Substantially Equivalent |
| K830395 | PEEPER | Mar 11, 1983 | Substantially Equivalent |
| K821434 | EKG (ECG) ELECTRODES | Jul 30, 1982 | Substantially Equivalent |