The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hp Model M1020a, Arterial Oxygen Sat/pleth Module.
Device ID | K903523 |
510k Number | K903523 |
Device Name: | HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE |
Classification | Oximeter |
Applicant | HEWLETT-PACKARD CO. SCHUCKARDSTRABE 4 7030 BOBLINGEN Germany, DE |
Contact | Gerhard Lenke |
Correspondent | Gerhard Lenke HEWLETT-PACKARD CO. SCHUCKARDSTRABE 4 7030 BOBLINGEN Germany, DE |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-06 |
Decision Date | 1990-10-23 |