The following data is part of a premarket notification filed by Advanced Instruments, Inc. with the FDA for Osmometer Model 2400.
| Device ID | K911092 |
| 510k Number | K911092 |
| Device Name: | OSMOMETER MODEL 2400 |
| Classification | Osmometer For Clinical Use |
| Applicant | ADVANCED INSTRUMENTS, INC. 1000 HIGHLAND AVE. Needham Heights, MA 02194 |
| Contact | Douglas Guerette |
| Correspondent | Douglas Guerette ADVANCED INSTRUMENTS, INC. 1000 HIGHLAND AVE. Needham Heights, MA 02194 |
| Product Code | JJM |
| CFR Regulation Number | 862.2730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-11 |
| Decision Date | 1991-05-22 |