510(k) K953937
K953937 is an FDA 510(k) premarket notification submitted by Apt Technology, Inc. for the device "LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEM". The FDA issued a decision of Substantially Equivalent on October 31, 1995. The device falls under product code IQA (System, Environmental Control, Powered), a Class II device regulated under 21 CFR 890.3725. Apt Technology, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1995
- Date Received
- August 18, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Environmental Control, Powered
- Device Class
- Class II
- Regulation Number
- 890.3725
- Review Panel
- PM
- Submission Type