NEOLEAD
Electrode, Electrocardiograph
NEOTECH PRODUCTS, INC.
The following data is part of a premarket notification filed by Neotech Products, Inc. with the FDA for Neolead.
Pre-market Notification Details
| Device ID | K011564 |
| 510k Number | K011564 |
| Device Name: | NEOLEAD |
| Classification | Electrode, Electrocardiograph |
| Applicant | NEOTECH PRODUCTS, INC. 9135-F ALABAMA AVE. Chatsworth, CA 91311 |
| Contact | Arnold M Heyman |
| Correspondent | Arnold M Heyman NEOTECH PRODUCTS, INC. 9135-F ALABAMA AVE. Chatsworth, CA 91311 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-21 |
| Decision Date | 2002-01-03 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884838035199 | K011564 | 000 |
| 20884838035182 | K011564 | 000 |
| 20884838035175 | K011564 | 000 |
| 20884838035168 | K011564 | 000 |
| 20884838035151 | K011564 | 000 |
| 20884838035144 | K011564 | 000 |
| 20884838035137 | K011564 | 000 |
| 20884838035106 | K011564 | 000 |
Trademark Results [NEOLEAD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEOLEAD 78461237 2998104 Live/Registered |
NEOTECH PRODUCTS LLC 2004-08-03 |
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