The following data is part of a premarket notification filed by Advanced Instruments, Inc. with the FDA for Osmometer Model 3w11.
Device ID | K790611 |
510k Number | K790611 |
Device Name: | OSMOMETER MODEL 3W11 |
Classification | Osmometer For Clinical Use |
Applicant | ADVANCED INSTRUMENTS, INC. SHORASHIM |
Product Code | JJM |
CFR Regulation Number | 862.2730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-03-29 |
Decision Date | 1979-06-15 |