The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hewlett-packard Model M1020a Pulse Oximeter.
Device ID | K923343 |
510k Number | K923343 |
Device Name: | HEWLETT-PACKARD MODEL M1020A PULSE OXIMETER |
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 | 1992-06-18 |
Decision Date | 1993-02-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884838011915 | K923343 | 000 |