The following data is part of a premarket notification filed by Hewlett-packard Gmbh with the FDA for Hewlett-packard M1021a Mix Ven Oxy Sat Plug-in Module.
Device ID | K942842 |
510k Number | K942842 |
Device Name: | HEWLETT-PACKARD M1021A MIX VEN OXY SAT PLUG-IN MODULE |
Classification | Oximeter |
Applicant | HEWLETT-PACKARD GMBH MEDIZINELEKTRONIK POSTFACH 1427 71004 Boblingen, DE |
Contact | Egon Pfeil |
Correspondent | Egon Pfeil HEWLETT-PACKARD GMBH MEDIZINELEKTRONIK POSTFACH 1427 71004 Boblingen, DE |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-16 |
Decision Date | 1995-02-16 |