The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Datex-ohmeda Tonometry Module M-tono.
| Device ID | K993656 |
| 510k Number | K993656 |
| Device Name: | DATEX-OHMEDA TONOMETRY MODULE M-TONO |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | DATEX-OHMEDA, INC. 3 HIGHWOOD DR. Tewksbury, MA 01876 |
| Contact | Joel C Kent |
| Correspondent | Joel C Kent DATEX-OHMEDA, INC. 3 HIGHWOOD DR. Tewksbury, MA 01876 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-29 |
| Decision Date | 2000-03-15 |
| Summary: | summary |