The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Infinity Etco2 + Respiratory Mechanics Pod.
| Device ID | K003550 |
| 510k Number | K003550 |
| Device Name: | INFINITY ETCO2 + RESPIRATORY MECHANICS POD |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Contact | Penelope H Green |
| Correspondent | Penelope H Green SIEMENS MEDICAL SOLUTIONS USA, INC. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-17 |
| Decision Date | 2001-03-07 |