510(k) K914273
K914273 is an FDA 510(k) premarket notification submitted by A&D Engineering, Inc. for the device "A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR". The FDA issued a decision of Substantially Equivalent on February 9, 1993. The device falls under product code DSK (Computer, Blood-Pressure), a Class II device regulated under 21 CFR 870.1110. A&D Engineering, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 1993
- Date Received
- September 24, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Blood-Pressure
- Device Class
- Class II
- Regulation Number
- 870.1110
- Review Panel
- CV
- Submission Type