The following data is part of a premarket notification filed by Sensormedics Corp. with the FDA for Modification To: Sipap Infant Nasal Cpap Circuit.
| Device ID | K012034 |
| 510k Number | K012034 |
| Device Name: | MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Contact | Alex Stenzler |
| Correspondent | Alex Stenzler SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-29 |
| Decision Date | 2001-07-24 |
| Summary: | summary |