SENSATRACE
Electrode, Electrocardiograph
LUDLOW CORP., TECHNICAL PAPERS DIVISION
The following data is part of a premarket notification filed by Ludlow Corp., Technical Papers Division with the FDA for Sensatrace.
Pre-market Notification Details
| Device ID | K904185 |
| 510k Number | K904185 |
| Device Name: | SENSATRACE |
| Classification | Electrode, Electrocardiograph |
| Applicant | LUDLOW CORP., TECHNICAL PAPERS DIVISION TWO LUDLOW PARK Chicopee, MA 01021 |
| Contact | Jay Ruehlen |
| Correspondent | Jay Ruehlen LUDLOW CORP., TECHNICAL PAPERS DIVISION TWO LUDLOW PARK Chicopee, MA 01021 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-12 |
| Decision Date | 1990-10-31 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884838000852 | K904185 | 000 |
Trademark Results [SENSATRACE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SENSATRACE 74104007 1730281 Dead/Cancelled |
Ludlow Corporation 1990-10-09 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.