The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hewlett Packard Anesthetic Gas Analyzer M1025a.
Device ID | K896216 |
510k Number | K896216 |
Device Name: | HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025A |
Classification | Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) |
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 | CBS |
CFR Regulation Number | 868.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-30 |
Decision Date | 1990-01-16 |