FETALGARD LITE
System, Monitoring, Perinatal
ANALOGIC CORP.
The following data is part of a premarket notification filed by Analogic Corp. with the FDA for Fetalgard Lite.
Pre-market Notification Details
| Device ID | K002503 |
| 510k Number | K002503 |
| Device Name: | FETALGARD LITE |
| Classification | System, Monitoring, Perinatal |
| Applicant | ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
| Contact | Steven A Clarke |
| Correspondent | Steven A Clarke ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-14 |
| Decision Date | 2000-11-09 |
Trademark Results [FETALGARD LITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FETALGARD LITE 75917331 2503057 Live/Registered |
Analogic Corporation 2000-02-14 |
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