The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Modification To: Datex-ohmeda Cardiocap 5 (rev B) And Accessories.
| Device ID | K012837 |
| 510k Number | K012837 |
| Device Name: | MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES |
| Classification | Monitor, St Segment With Alarm |
| Applicant | DATEX-OHMEDA 86 PILGRIM RD. Needham, MA 02492 |
| Contact | Joel C Kent |
| Correspondent | Joel C Kent DATEX-OHMEDA 86 PILGRIM RD. Needham, MA 02492 |
| Product Code | MLD |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-23 |
| Decision Date | 2001-09-14 |
| Summary: | summary |