510(k) K092408
- Device
- RHYTHM OF LIFE, MODEL R0901-05
- Applicant
- RAPID RESPONSE SOLUTIONS, LLC
- 510(k) number
- K092408
- Product code
- LIX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-10-14
- Date received
- 2009-08-06
- Regulation
- 870.5210
- Classification name
- Aid, Cardiopulmonary Resuscitation
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JORGE MILAN
- Address
- 601 W. 20 St. Hialeah FL US 33010 33010
FDA Registration Numbers#
- 3013500228
- 1930027
- 3013557562
- 3000126629
- 3008717264
- 3013596024
- 3030446844
- 8030978
- 3003832357
- 9610483
- 3030733800
- 3009077524
- 3031563234
- 3010317211
- 3007029079
- 1220908
- 3004906872
Source Documents#
Other 510(k) Records For Product Code LIX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201581 | CPR BAND | Credo | 2021-03-06 |
| K183348 | Reusable Silicone Cover CPRmeter 2 | Laerdal Medical AS | 2018-12-17 |
| K173886 | CPRmeter 2 CPR Feedback Device | Laerdal Medical AS | 2018-03-23 |
| K151702 | Reusable Full Silicone Cover | Laerdal Medical AS | 2015-08-13 |
| K123248 | CPR RSQ ASSIST | Avantech, Inc. | 2013-12-10 |
| K123597 | TRUECPR COACHING DEVICE | Physio-Control, Inc. | 2013-04-17 |
| K122050 | CPRMETER CPR FEEDBACK DEVICE | Laerdal Medical A/S | 2012-10-22 |
| K112660 | POCKETCPR | Zoll Medical Corp | 2012-05-10 |
| K071321 | POCKETCPR | Bio-Detek, Inc. | 2007-09-12 |
| K010526 | MODIFICATION TO THE GRIP | Elcare Innovations, Inc. | 2001-12-13 |
| K003937 | CPR EZY MASK AND PAD | Medteq Innovations Pty, Ltd. | 2001-06-06 |
| K954692 | CPR PROMPT | County Line , Ltd. | 1996-03-27 |
| K926333 | CPR PLUS | Kells Medical, Inc. | 1993-11-08 |
| K900415 | C.P.R. LANDMARC | Can-Am Medical, Inc. | 1990-06-12 |
| K843977 | PULSE-AID DEVICE | James J. Lally | 1985-02-01 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases