510(k) K014157
- Device
- HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A
- Applicant
- PHILIPS MEDICAL SYSTEMS
- 510(k) number
- K014157
- Product code
- MKJ
- Decision
- Se Subject To Tracking Reg (ST)
- Decision date
- 2002-01-17
- Date received
- 2001-12-19
- Regulation
- 870.5310
- Classification name
- Automated External Defibrillators (non-wearable)
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 3
- Clearance type
- Special
- Third party reviewed
- No
Applicant Contact#
- Contact
- TAMARA YOUNT
- Address
- 2401 Fourth Ave., Suite 500 Seattle WA US 98121 98121
FDA Registration Numbers#
- 1223925
- 1219103
- 1930027
- 3012502601
- 3015134086
- 3003800159
- 9681191
- 2112020
- 3013557562
- 3002714378
- 3004906872
- 3004123209
- 3009886119
- 3013500228
- 3005621729
- 3030677
- 1423537
- 1320894
- 3013517171
- 3015997711
- 3010783192
- 3004035727
- 3008717264
- 3012104670
- 3005906887
- 3012494290
- 3000126629
- 3030446844
- 3012607778
- 3010317211
- 3010839093
- 3003521780
- 3020460367
- 3006108746
- 3010703925
- 3043226252
- 3012972516
- 1423662
- 3021559257
- 8020045
- 3002807314
- 3030733800
- 1720929
- 3015876
- 3009077524
- 3010030355
- 1220908
- 3038259592
- 3003867964
- 3027815
- 2132111
- 1317188
- 3003537036
- 3026976873
- 1218058
- 3014579161
- 9681860
- 3026007685
- 3007029079
- 3011823740
- 3017422354
- 3029871637
- 1921846
- 3013596024
- 3021632375
- 3013826848
- 3014572985
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MKJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K143714 | Powerheart G5 AED | Cardiac Science Corporation | 2015-05-04 |
| K150055 | OneStep Pediatric CPR Multi-Function Electrode | Bio-Detek, Inc. | 2015-05-02 |
| K150198 | CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel | Bio-Detek, Inc. | 2015-05-02 |
| K142709 | samaritan PAD 450P | Heartsine Technologies, Inc. | 2015-03-27 |
| K133659 | HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING | Philips Medical Systems | 2015-01-23 |
| K133239 | ZOLL E SERIES | Zoll Medical Corporation, World Wide Headquarters | 2015-01-16 |
| K142430 | LIFEPAK 15 monitor/defibrillator | Physio-Control, Inc. | 2014-12-19 |
| K141795 | BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 | R & D Batteries, Inc. | 2014-12-08 |
| K142915 | ZOLL X Series | ZOLL Medical Corporation | 2014-12-03 |
| K142803 | Skintact, various other tradenames | Leonhard Lang GmbH | 2014-12-02 |
| K141231 | ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY | Zeller Power Products (Battery Beast, LLC) | 2014-11-25 |
| K141774 | ZOLL X SERIES | ZOLL Medical Corporation | 2014-11-19 |
| K133441 | ONESTEP CPR II MULTI-FUNCTION ELECTRODE | Bio-Detek, Inc. | 2014-10-10 |
| K133484 | ZOLL X SERIES | Zoll Medical Corp | 2014-08-01 |
| K133269 | ZOLL X SERIES | Zoll Medical Corporation, World Wide Headquarters | 2014-05-22 |
Legacy Summary#
summary
FDA Review#
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