The following data is part of a premarket notification filed by Excel Medical Electronics, Llc with the FDA for Wave Clinical Platform.
| Device ID | K171056 |
| 510k Number | K171056 |
| Device Name: | WAVE Clinical Platform |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Excel Medical Electronics, LLC 801 Maplewood Dr. STE-25 Jupiter, FL 33458 |
| Contact | Lance Burton |
| Correspondent | Lance Burton Excel Medical Electronics, LLC 801 Maplewood Dr. STE-25 Jupiter, FL 33458 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-10 |
| Decision Date | 2018-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856128007007 | K171056 | 000 |
| 00887761975354 | K171056 | 000 |