The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Conmed Ekg Stripper.
| Device ID | K960264 |
| 510k Number | K960264 |
| Device Name: | CONMED EKG STRIPPER |
| Classification | Electrode, Electrocardiograph |
| Applicant | CONMED CORP. P.O. BOX 1408 Dayton, OH 45401 -1408 |
| Contact | Ira D Duesler, Jr. |
| Correspondent | Ira D Duesler, Jr. CONMED CORP. P.O. BOX 1408 Dayton, OH 45401 -1408 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-18 |
| Decision Date | 1996-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20653405001123 | K960264 | 000 |
| 20653405000898 | K960264 | 000 |
| 20653405005954 | K960264 | 000 |
| 20653405005930 | K960264 | 000 |