The following data is part of a premarket notification filed by Rapid Response Solutions, Llc with the FDA for Rhythm Of Life, Model R0901-05.
| Device ID | K092408 |
| 510k Number | K092408 |
| Device Name: | RHYTHM OF LIFE, MODEL R0901-05 |
| Classification | Aid, Cardiopulmonary Resuscitation |
| Applicant | RAPID RESPONSE SOLUTIONS, LLC 601 WEST 20 STREET Hialeah, FL 33010 |
| Contact | Jorge Milan |
| Correspondent | Jorge Milan RAPID RESPONSE SOLUTIONS, LLC 601 WEST 20 STREET Hialeah, FL 33010 |
| Product Code | LIX |
| CFR Regulation Number | 870.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-06 |
| Decision Date | 2009-10-14 |
| Summary: | summary |