510(k) K820135

TAYLOR & TYCOS ACOUSTIC SPHYGMOMANOMETER by Sybron Corp. — Product Code DXN

K820135 is an FDA 510(k) premarket notification submitted by Sybron Corp. for the device "TAYLOR & TYCOS ACOUSTIC SPHYGMOMANOMETER". The FDA issued a decision of Substantially Equivalent on March 1, 1982. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Sybron Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1982
Date Received
January 18, 1982
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