510(k) K843977
- Device
- PULSE-AID DEVICE
- Applicant
- JAMES J. LALLY
- 510(k) number
- K843977
- Product code
- LIX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-02-01
- Date received
- 1984-10-05
- Regulation
- 870.5210
- Classification name
- Aid, Cardiopulmonary Resuscitation
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES J LALLY
- Address
- 4620 J.C. Nichols Pkwy. Plz. Pkwy. Bldg. Kansas City MO US 64112 64112
FDA Registration Numbers#
- 3013500228
- 1930027
- 3013557562
- 3000126629
- 3008717264
- 3013596024
- 3030446844
- 8030978
- 3003832357
- 9610483
- 3030733800
- 3009077524
- 3031563234
- 3010317211
- 3007029079
- 1220908
- 3004906872
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K092408 | RHYTHM OF LIFE, MODEL R0901-05 | Rapid Response Solutions, LLC | 2009-10-14 |
| 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 |
Legacy Summary#
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FDA Review#
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