The following data is part of a premarket notification filed by Tyco Healthcare Nancy with the FDA for Purtian Bennett, Good Knight 420g Model M-113900-us; Purtan Bennett, Goodknight 420s Model M-113903-us.
Device ID | K020886 |
510k Number | K020886 |
Device Name: | PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US; PURTAN BENNETT, GOODKNIGHT 420S MODEL M-113903-US |
Classification | Ventilator, Non-continuous (respirator) |
Applicant | TYCO HEALTHCARE NANCY 10 ALLEE PELLETIER DOISY Villers-les-nancy, FR 54601 |
Contact | Moustafa Anki |
Correspondent | Moustafa Anki TYCO HEALTHCARE NANCY 10 ALLEE PELLETIER DOISY Villers-les-nancy, FR 54601 |
Product Code | BZD |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-03-18 |
Decision Date | 2002-11-01 |
Summary: | summary |