The following data is part of a premarket notification filed by Modular Instruments, Inc. with the FDA for Lifelog(tm).
Device ID | K902962 |
510k Number | K902962 |
Device Name: | LIFELOG(TM) |
Classification | Gas-machine, Anesthesia |
Applicant | MODULAR INSTRUMENTS, INC. 81 GREAT VALLEY PKWY. Malvern, PA 19355 |
Contact | Lynne Aronson |
Correspondent | Lynne Aronson MODULAR INSTRUMENTS, INC. 81 GREAT VALLEY PKWY. Malvern, PA 19355 |
Product Code | BSZ |
CFR Regulation Number | 868.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-05 |
Decision Date | 1990-09-04 |