The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Sleep Apnea Nasal Cpap System.
Device ID | K871693 |
510k Number | K871693 |
Device Name: | SLEEP APNEA NASAL CPAP SYSTEM |
Classification | Attachment, Breathing, Positive End Expiratory Pressure |
Applicant | PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
Contact | Hartley C Ericson |
Correspondent | Hartley C Ericson PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
Product Code | BYE |
CFR Regulation Number | 868.5965 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-29 |
Decision Date | 1987-09-15 |