The following data is part of a premarket notification filed by S.l.p. Ltd. with the FDA for Sleepsense Sleep Sensors.
Device ID | K042253 |
510k Number | K042253 |
Device Name: | SLEEPSENSE SLEEP SENSORS |
Classification | Ventilatory Effort Recorder |
Applicant | S.L.P. LTD. 18 HAZFIRA ST. Tel-aviv, IL 67779 |
Contact | Noam Hadas |
Correspondent | Patricia Murphy KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont, PA 18914 |
Product Code | MNR |
CFR Regulation Number | 868.2375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2004-08-20 |
Decision Date | 2004-10-06 |