The following data is part of a premarket notification filed by Sensormedics Corp. with the FDA for Vmax229 Series Pulmonary/metabolic Systems.
| Device ID | K942211 |
| 510k Number | K942211 |
| Device Name: | VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Contact | Paul L Kittinger |
| Correspondent | Paul L Kittinger SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-05 |
| Decision Date | 1994-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10190752163300 | K942211 | 000 |
| 10190752118089 | K942211 | 000 |
| 10190752117501 | K942211 | 000 |
| 10190752117396 | K942211 | 000 |
| 10190752117372 | K942211 | 000 |
| 10190752117365 | K942211 | 000 |
| 10190752117358 | K942211 | 000 |
| 10190752168244 | K942211 | 000 |
| 10190752164826 | K942211 | 000 |
| 10190752164055 | K942211 | 000 |
| 10190752162013 | K942211 | 000 |
| 10190752117822 | K942211 | 000 |
| 10190752114289 | K942211 | 000 |
| 10190752114036 | K942211 | 000 |
| 10190752118140 | K942211 | 000 |
| 10190752160859 | K942211 | 000 |
| 10190752163010 | K942211 | 000 |
| 10190752162549 | K942211 | 000 |
| 10190752166882 | K942211 | 000 |
| 10190752164765 | K942211 | 000 |
| 10190752164567 | K942211 | 000 |
| 10190752164413 | K942211 | 000 |
| 10190752164406 | K942211 | 000 |
| 10190752164376 | K942211 | 000 |
| 10190752164260 | K942211 | 000 |
| 10190752164253 | K942211 | 000 |
| 10190752164246 | K942211 | 000 |
| 10190752164154 | K942211 | 000 |
| 10190752163997 | K942211 | 000 |
| 10190752163522 | K942211 | 000 |
| 10190752114029 | K942211 | 000 |