510(k) K933886

TOA MEDICAL ELECTRONICS CA-5000 by Toa Medical Electronics USA, Inc. — Product Code JPA

K933886 is an FDA 510(k) premarket notification submitted by Toa Medical Electronics USA, Inc. for the device "TOA MEDICAL ELECTRONICS CA-5000". The FDA issued a decision of Substantially Equivalent on January 27, 1994. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Toa Medical Electronics USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1994
Date Received
August 10, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Multipurpose For In Vitro Coagulation Studies
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type