The following data is part of a premarket notification filed by Credo with the FDA for Cpr Band.
| Device ID | K201581 |
| 510k Number | K201581 |
| Device Name: | CPR BAND |
| Classification | Aid, Cardiopulmonary Resuscitation |
| Applicant | CREDO #302, 86, Baeul-ro Wonju-si, KR 26465 |
| Contact | Ji Hyo Wang |
| Correspondent | Dongha Lee KMC, Inc. Room No. 904, 27, Digital-ro 27ga-gil, Guro-gu Seoul, KR 08375 |
| Product Code | LIX |
| CFR Regulation Number | 870.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-11 |
| Decision Date | 2021-03-06 |