The following data is part of a premarket notification filed by Siemens Medical Electronics with the FDA for Siemens Sirecust Transcutaneous Carbon Dioxide.
| Device ID | K891481 |
| 510k Number | K891481 |
| Device Name: | SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE |
| Classification | Monitor, Carbon-dioxide, Cutaneous |
| Applicant | SIEMENS MEDICAL ELECTRONICS 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Contact | Robert R Murfitt |
| Correspondent | Robert R Murfitt SIEMENS MEDICAL ELECTRONICS 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Product Code | LKD |
| CFR Regulation Number | 868.2480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-17 |
| Decision Date | 1989-09-29 |