THE BREATHER
Spirometer, Therapeutic (incentive)
PAL MEDICAL, INC.
The following data is part of a premarket notification filed by Pal Medical, Inc. with the FDA for The Breather.
Pre-market Notification Details
| Device ID | K944412 |
| 510k Number | K944412 |
| Device Name: | THE BREATHER |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | PAL MEDICAL, INC. 2012 1/2 CURRY FORD RD. Orlando, FL 32806 |
| Contact | Peggy Nicholson |
| Correspondent | Peggy Nicholson PAL MEDICAL, INC. 2012 1/2 CURRY FORD RD. Orlando, FL 32806 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-08 |
| Decision Date | 1995-04-26 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08652020001004 | K944412 | 000 |
| 00865202000124 | K944412 | 000 |
| 01240000013856 | K944412 | 000 |
| 00850021574345 | K944412 | 000 |
Trademark Results [THE BREATHER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THE BREATHER 98392365 not registered Live/Pending |
PN MEDICAL, INC. 2024-02-05 |
 THE BREATHER 73830885 1607377 Live/Registered |
PAL MEDICAL, INC. 1989-10-12 |
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