The following data is part of a premarket notification filed by Tz Medical, Inc. with the FDA for V1 Multi-port Connector, Model Pad V1-mpc.
Device ID | K062577 |
510k Number | K062577 |
Device Name: | V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC |
Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
Applicant | TZ MEDICAL, INC. 7272 S.W. DURHAM RD., #800 Portland, OR 97224 |
Contact | Madalyn Duncan |
Correspondent | Madalyn Duncan TZ MEDICAL, INC. 7272 S.W. DURHAM RD., #800 Portland, OR 97224 |
Product Code | DSA |
CFR Regulation Number | 870.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-08-31 |
Decision Date | 2006-12-15 |