The following data is part of a premarket notification filed by Medtronic , Inc. with the FDA for Medtronic Model 5492a, 5492v, 5492al, 5492vl Patient Cables.
| Device ID | K203556 |
| 510k Number | K203556 |
| Device Name: | Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | Medtronic , Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Contact | Alexandra Theisen |
| Correspondent | Alexandra Theisen Medtronic , Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-07 |
| Decision Date | 2021-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169889705 | K203556 | 000 |
| 00643169889668 | K203556 | 000 |