BioStamp NPoint
Transmitters And Receivers, Physiological Signal, Radiofrequency
MC10 Inc.
The following data is part of a premarket notification filed by Mc10 Inc. with the FDA for Biostamp Npoint.
Pre-market Notification Details
| Device ID | K173510 |
| 510k Number | K173510 |
| Device Name: | BioStamp NPoint |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | MC10 Inc. 10 Maguire Road Bldg 3 First Floor Lexington, MA 02421 |
| Contact | Rakesh Lal |
| Correspondent | Jonathan Kahan Hogan Lovells 555 13th St. NW Washington, DC 20004 |
| Product Code | DRG |
| Subsequent Product Code | IKN |
| Subsequent Product Code | LEL |
| Subsequent Product Code | MWI |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-13 |
| Decision Date | 2018-05-08 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G012MC0009 | K173510 | 000 |
| G012MC0007 | K173510 | 000 |
| G012MC0008 | K173510 | 000 |
| G012MC0012 | K173510 | 000 |
| G012MC0013 | K173510 | 000 |
| G012MC0014 | K173510 | 000 |
| G012MC0015 | K173510 | 000 |
| G012SW0025 | K173510 | 000 |
| G012SW0026 | K173510 | 000 |
| G012SW0027 | K173510 | 000 |
| G012SW0028 | K173510 | 000 |
| G012MC0006 | K173510 | 000 |
| G012MC0005 | K173510 | 000 |
| G012BRCA05 | K173510 | 000 |
| G012BRCD02 | K173510 | 000 |
| G012BRCP01 | K173510 | 000 |
| G012BRCP02 | K173510 | 000 |
| G012BRCP03 | K173510 | 000 |
| G012BRCS02 | K173510 | 000 |
| G012BRCT01 | K173510 | 000 |
| G012BSPS01 | K173510 | 000 |
| G012MC0003 | K173510 | 000 |
| G012MC0004 | K173510 | 000 |
| G012MC00022 | K173510 | 000 |
| B493MC0009 | K173510 | 000 |
| B493MC0006 | K173510 | 000 |
| B493MC0007 | K173510 | 000 |
| B493MC0008 | K173510 | 000 |
| B493MC0012 | K173510 | 000 |
| B493MC0013 | K173510 | 000 |
| B493MC0014 | K173510 | 000 |
| B493MC0015 | K173510 | 000 |
| B493SW0025 | K173510 | 000 |
| B493SW0026 | K173510 | 000 |
| B493SW0027 | K173510 | 000 |
| B493MC0005 | K173510 | 000 |
| B493MC0004 | K173510 | 000 |
| B493BRCA05 | K173510 | 000 |
| B493BRCD01 | K173510 | 000 |
| B493BRCD02 | K173510 | 000 |
| B493BRCP01 | K173510 | 000 |
| B493BRCP02 | K173510 | 000 |
| B493BRCP03 | K173510 | 000 |
| B493BRCS02 | K173510 | 000 |
| B493BRCT01 | K173510 | 000 |
| B493BSPS01 | K173510 | 000 |
| B493MC0003 | K173510 | 000 |
| B493SW0028 | K173510 | 000 |
Trademark Results [BioStamp NPoint]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOSTAMP NPOINT 87446310 5460543 Live/Registered |
MC10, Inc. 2017-05-11 |
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