The following data is part of a premarket notification filed by Deltex Medical Limited with the FDA for Deltex Medical Kdp72 Doppler Probe.
Device ID | K142932 |
510k Number | K142932 |
Device Name: | Deltex Medical KDP72 Doppler Probe |
Classification | Probe, Blood-flow, Extravascular |
Applicant | DELTEX MEDICAL LIMITED TERMINUS RD. Chichester, West Sussex, GB Po19 2tx |
Contact | Paul Dwane |
Correspondent | Neil R Armstrong MeddiQuest Limited Quest Science, Orton Malborne Peterborough, GB Pe2 5xs |
Product Code | DPT |
CFR Regulation Number | 870.2120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-10-09 |
Decision Date | 2015-01-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
5055679406122 | K142932 | 000 |