The following data is part of a premarket notification filed by Charter Medical, Ltd. with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration Follow Fda En Español Search Fda Home Food Drugs Medical Devices .
| Device ID | BK170004 |
| 510k Number | BK170004 |
| Device Name: | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices |
| Classification | Set, Transfer (blood/plasma) |
| Applicant | Charter Medical, Ltd. 3948-a Westpoint Blvd. Winston-salem, NC 27103 |
| Product Code | KSB |
| CFR Regulation Number | 864.9875 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-13 |
| Decision Date | 2017-10-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817827026669 | BK170004 | 0 |
| 00817827026546 | BK170004 | 0 |
| 00817827026539 | BK170004 | 0 |
| 00817827026522 | BK170004 | 0 |
| 00817827026515 | BK170004 | 0 |
| 00817827026713 | BK170004 | 0 |
| 00817827026706 | BK170004 | 0 |
| 00817827026690 | BK170004 | 0 |
| 00817827026683 | BK170004 | 0 |
| 00817827026553 | BK170004 | 0 |
| 00817827026560 | BK170004 | 0 |
| 00817827026577 | BK170004 | 0 |
| 00817827026652 | BK170004 | 0 |
| 00817827026645 | BK170004 | 0 |
| 00817827026638 | BK170004 | 0 |
| 00817827026621 | BK170004 | 0 |
| 00817827026614 | BK170004 | 0 |
| 00817827026607 | BK170004 | 0 |
| 00817827026591 | BK170004 | 0 |
| 00817827026584 | BK170004 | 0 |
| 00817827026676 | BK170004 | 0 |