The following data is part of a premarket notification filed by Triton Technology, Inc. with the FDA for Triton Model 100 Pulsed Doppler Blood Flowmeter.
Device ID | K881303 |
510k Number | K881303 |
Device Name: | TRITON MODEL 100 PULSED DOPPLER BLOOD FLOWMETER |
Classification | Probe, Blood-flow, Extravascular |
Applicant | TRITON TECHNOLOGY, INC. P.O. BOX 99185 San Diego, CA 92109 |
Contact | Scott Kemper |
Correspondent | Scott Kemper TRITON TECHNOLOGY, INC. P.O. BOX 99185 San Diego, CA 92109 |
Product Code | DPT |
CFR Regulation Number | 870.2120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-28 |
Decision Date | 1988-11-29 |