The following data is part of a premarket notification filed by Respire Medical Holdings with the FDA for Respire Pink At (hard, Hard/soft, Ef).
Device ID | K192127 |
510k Number | K192127 |
Device Name: | Respire Pink AT (Hard, Hard/Soft, EF) |
Classification | Device, Anti-snoring |
Applicant | Respire Medical Holdings 18 Bridge St. Suite 3J Brooklyn, NY 11201 |
Contact | Madubuike Okafor |
Correspondent | Madubuike Okafor Respire Medical Holdings 18 Bridge St. Suite 3J Brooklyn, NY 11201 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-08-06 |
Decision Date | 2020-02-05 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00851861007277 | K192127 | 000 |
00851861007260 | K192127 | 000 |
00851861007253 | K192127 | 000 |