INTROSCOPE
Stethoscope, Esophageal, With Electrical Conductors
POLAMEDCO, INC.
The following data is part of a premarket notification filed by Polamedco, Inc. with the FDA for Introscope.
Pre-market Notification Details
| Device ID | K953793 |
| 510k Number | K953793 |
| Device Name: | INTROSCOPE |
| Classification | Stethoscope, Esophageal, With Electrical Conductors |
| Applicant | POLAMEDCO, INC. 4054 GLENCOE AVE. Marina Del Rey, CA 90292 -5608 |
| Contact | Corey Selman |
| Correspondent | Corey Selman POLAMEDCO, INC. 4054 GLENCOE AVE. Marina Del Rey, CA 90292 -5608 |
| Product Code | BZT |
| CFR Regulation Number | 868.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-14 |
| Decision Date | 1995-11-29 |
Trademark Results [INTROSCOPE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTROSCOPE 75945227 2509039 Live/Registered |
Wily Technology, Inc. 2000-02-24 |
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