510(k) K871901
K871901 is an FDA 510(k) premarket notification submitted by Custom Industries, Inc. for the device "ULTRAFLOW". The FDA issued a decision of Substantially Equivalent on June 1, 1987. The device falls under product code FZH (Apparatus, Air Handling, Room), a Class II device regulated under 21 CFR 878.5070.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 1, 1987
- Date Received
- May 15, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Air Handling, Room
- Device Class
- Class II
- Regulation Number
- 878.5070
- Review Panel
- SU
- Submission Type