The following data is part of a premarket notification filed by Innomed Technologies with the FDA for It Nasal Mask.
Device ID | K050171 |
510k Number | K050171 |
Device Name: | IT NASAL MASK |
Classification | Ventilator, Non-continuous (respirator) |
Applicant | INNOMED TECHNOLOGIES 6601 LYONS ROAD SUITES B1-B-4 Coconut Creek, FL 33073 |
Contact | Frank Pelc |
Correspondent | Frank Pelc INNOMED TECHNOLOGIES 6601 LYONS ROAD SUITES B1-B-4 Coconut Creek, FL 33073 |
Product Code | BZD |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-01-26 |
Decision Date | 2005-05-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10607411945547 | K050171 | 000 |
10607411942133 | K050171 | 000 |
10607411942140 | K050171 | 000 |
10607411942157 | K050171 | 000 |
10607411942164 | K050171 | 000 |
10607411942171 | K050171 | 000 |
10607411942188 | K050171 | 000 |
10607411942195 | K050171 | 000 |
10607411945479 | K050171 | 000 |
10607411945486 | K050171 | 000 |
10607411945493 | K050171 | 000 |
10607411945509 | K050171 | 000 |
10607411945516 | K050171 | 000 |
10607411945523 | K050171 | 000 |
10607411945530 | K050171 | 000 |
10607411942126 | K050171 | 000 |