The following data is part of a premarket notification filed by Tyco Healthcare Nancy with the FDA for Puritan Bennett, Goodknight 420 Evolution, Model M-113903-us.
Device ID | K031470 |
510k Number | K031470 |
Device Name: | PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US |
Classification | Ventilator, Non-continuous (respirator) |
Applicant | TYCO HEALTHCARE NANCY NELLCOR PURITAN BENNETT DIV. 4280 HACIENDA DRIVE Pleasanton, CA 94588 |
Contact | James Bonds |
Correspondent | James Bonds TYCO HEALTHCARE NANCY NELLCOR PURITAN BENNETT DIV. 4280 HACIENDA DRIVE Pleasanton, CA 94588 |
Product Code | BZD |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-05-09 |
Decision Date | 2003-06-05 |
Summary: | summary |