The following data is part of a premarket notification filed by Sensormedics Corp. with the FDA for Static And Dynamic Compliance, A Respiratory Mechanics Option For The Vmax Series.
| Device ID | K981366 |
| 510k Number | K981366 |
| Device Name: | STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Contact | Larry Murdock |
| Correspondent | Larry Murdock 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 | 1998-04-15 |
| Decision Date | 1998-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250892905679 | K981366 | 000 |
| 04250892905662 | K981366 | 000 |