The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for The Puritan-bennett 318 Plus Nasal Cpap System.
Device ID | K960518 |
510k Number | K960518 |
Device Name: | THE PURITAN-BENNETT 318 PLUS NASAL CPAP SYSTEM |
Classification | Ventilator, Non-continuous (respirator) |
Applicant | PURITAN BENNETT CORP. 9728 PFLUMM RD. P.O.BOX 15915 Lenexa, KS 66215 -5915 |
Contact | C. Marshall Smith |
Correspondent | C. Marshall Smith PURITAN BENNETT CORP. 9728 PFLUMM RD. P.O.BOX 15915 Lenexa, KS 66215 -5915 |
Product Code | BZD |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-02-05 |
Decision Date | 1996-05-09 |
Summary: | summary |