510(k) K875305
K875305 is an FDA 510(k) premarket notification submitted by Spec Systems, Inc. for the device "MODEL UCA / SPEC SYSTEM UCA". The FDA issued a decision of Substantially Equivalent on January 27, 1988. The device falls under product code FZH (Apparatus, Air Handling, Room), a Class II device regulated under 21 CFR 878.5070. Spec Systems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 1988
- Date Received
- December 29, 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