The following data is part of a premarket notification filed by Fiske Med Science with the FDA for Osmometer Model Om-6010.
| Device ID | K811179 |
| 510k Number | K811179 |
| Device Name: | OSMOMETER MODEL OM-6010 |
| Classification | Osmometer For Clinical Use |
| Applicant | FISKE MED SCIENCE 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | JJM |
| CFR Regulation Number | 862.2730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-28 |
| Decision Date | 1981-05-15 |