The following data is part of a premarket notification filed by Pajunk Gmbh Medizintechnologie with the FDA for Vpc.
Device ID | K190345 |
510k Number | K190345 |
Device Name: | VPC |
Classification | Anesthesia Conduction Kit |
Applicant | Pajunk GmbH Medizintechnologie Karl-Hall-Str. 1 Geisingen, DE 78187 |
Contact | Christian G.h Quass |
Correspondent | Christian G.h Quass Pajunk GmbH Medizintechnologie Karl-Hall-Str. 1 Geisingen, DE 78187 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-02-14 |
Decision Date | 2019-05-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04048223040393 | K190345 | 000 |
04048223033241 | K190345 | 000 |