510(k) K873979
K873979 is an FDA 510(k) premarket notification submitted by Dynamedics, Inc. for the device "DYNAMARK 1000". The FDA issued a decision of Substantially Equivalent on November 27, 1987. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Dynamedics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 27, 1987
- Date Received
- September 30, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Measurement, Blood-Pressure, Non-Invasive
- Device Class
- Class II
- Regulation Number
- 870.1130
- Review Panel
- CV
- Submission Type