The following data is part of a premarket notification filed by Columbus Instruments Intl. Corp. with the FDA for Iso-thermex.
| Device ID | K861100 |
| 510k Number | K861100 |
| Device Name: | ISO-THERMEX |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | COLUMBUS INSTRUMENTS INTL. CORP. P.O. BOX 44049 Columbus, OH 43204 |
| Contact | Czekajewski, Phd |
| Correspondent | Czekajewski, Phd COLUMBUS INSTRUMENTS INTL. CORP. P.O. BOX 44049 Columbus, OH 43204 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-24 |
| Decision Date | 1986-05-12 |