Steth IO
Stethoscope, Electronic
STRATOSCIENTIFIC, INC.
The following data is part of a premarket notification filed by Stratoscientific, Inc. with the FDA for Steth Io.
Pre-market Notification Details
| Device ID | K160016 |
| 510k Number | K160016 |
| Device Name: | Steth IO |
| Classification | Stethoscope, Electronic |
| Applicant | STRATOSCIENTIFIC, INC. 1574 NORTHWEST 190TH STREET Shoreline, WA 98177 |
| Contact | Suman Mulumudi |
| Correspondent | Jim West BIOMEDICAL DEVICES OF KANSAS 1205 E US 24-40 HIGHWAY Tonganoxie, KS 66086 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-05 |
| Decision Date | 2016-07-15 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860135001934 | K160016 | 000 |
| 00860135001927 | K160016 | 000 |
| 00860135001910 | K160016 | 000 |
| 00860135001903 | K160016 | 000 |
Trademark Results [Steth IO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STETH IO 86507388 4884323 Live/Registered |
StratoScientific, Inc. 2015-01-19 |
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