SPIRO PD
Spirometer, Diagnostic
PMD HEALTHCARE
The following data is part of a premarket notification filed by Pmd Healthcare with the FDA for Spiro Pd.
Pre-market Notification Details
| Device ID | K103575 |
| 510k Number | K103575 |
| Device Name: | SPIRO PD |
| Classification | Spirometer, Diagnostic |
| Applicant | PMD HEALTHCARE 1468 HARWELL AVE. Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith PMD HEALTHCARE 1468 HARWELL AVE. Crofton, MD 21114 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-06 |
| Decision Date | 2011-11-09 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857845006007 | K103575 | 000 |
Trademark Results [SPIRO PD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPIRO PD 85453002 4325235 Live/Registered |
PMD Healthcare 2011-10-21 |
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