Apparatus, Air Handling, Room
The Apparatus, Air Handling, Room (product code FZH) is a room-level air handling system designed to control and direct airflow within a surgical or clinical space, helping to maintain sterile or clean environmental conditions during procedures. It is classified as FDA Class 2, which requires a 510(k) premarket submission to demonstrate substantial equivalence to a predicate device before marketing. The device is regulated under 21 CFR 878.5070 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
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Basic Information
- Product Code
- FZH
- Device Class
- FDA class 2
- Regulation Number
- 878.5070
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K923233 | CARDIO-PAK LAPAROTOMY PACK | Mar 20, 1993 | Unknown | Cardio-Med-Associates, Inc. |
| K875305 | MODEL UCA / SPEC SYSTEM UCA | Jan 27, 1988 | Substantially Equivalent | Spec Systems, Inc. |
| K871901 | ULTRAFLOW | Jun 01, 1987 | Substantially Equivalent | Custom Industries, Inc. |
| K770084 | OPERATING ROOM VENTILATOR | Feb 23, 1977 | Substantially Equivalent | Dupaco, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.