510(k) K002061
- Device
- A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR
- Applicant
- A&D Engineering, Inc.
- 510(k) number
- K002061
- Product code
- DRT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-01-19
- Date received
- 2000-07-06
- Regulation
- 870.2300
- Classification name
- Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- JERRY WANG
- Address
- 1555 Mccandless Dr. Milpitas CA US 95035 95035
FDA Registration Numbers#
- 3008717264
- 3026751377
- 3021343210
- 3013500228
- 3014848734
- 3011790297
- 3000126629
- 3020207731
- 3012528160
- 3010536822
- 1054713
- 3016674095
- 3013679558
- 9610105
- 3013826848
- 1000122786
- 3023272766
- 3012359877
- 3019388613
- 3021559257
- 3007603826
- 3009973336
- 3015181391
- 3031158
- 3003971136
- 3016931915
- 3018783526
- 3007048291
- 3009001657
- 3029871637
- 3017812398
- 3032109181
- 3008716327
- 3009499478
- 3014541700
- 3004415095
- 3017422354
- 3012104670
- 9710602
- 3003263092
- 3006979678
- 3009607734
- 3008483389
- 3010703925
- 3005877899
- 3007413079
- 3005521864
- 3005783425
- 8030229
- 9611252
- 3003800159
- 3016592682
- 3016618143
- 3009831876
- 2221819
- 3017760831
- 9681377
- 3010390468
- 1066270
- 1319390
- 3007836437
- 3017986070
- 3015328411
- 3012238587
- 3038259592
- 3015997711
- 3016852448
- 3010698831
- 3015876
- 2080783
- 3043479346
- 3003589956
- 3014739036
- 3008460104
- 3009077524
- 3010317211
- 3015282442
- 1220908
- 3016701404
- 3003294644
Source Documents#
510(k) summary PDF not indicated by FDA
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