510(k) K884804
- Device
- THE COACH
- Applicant
- PROMARK, INC.
- 510(k) number
- K884804
- Product code
- DRT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-05-19
- Date received
- 1988-11-17
- Regulation
- 870.2300
- Classification name
- Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- DENNIS K PAYNE
- Address
- 9838 Northeast 16th Bellevue WA US 98004 98004
FDA Registration Numbers
- 2221819
- 3005877899
- 9710602
- 1218950
- 3032109181
- 1054713
- 3009156722
- 3016701404
- 3009077524
- 3009001657
- 3013826848
- 3015282442
- 3015997711
- 3018783526
- 3021736577
- 3010390468
- 3008716327
- 3003294644
- 8030229
- 3026751377
- 3012238587
- 3009673645
- 3008460104
- 1221108
- 2080783
- 1066270
- 3009973336
- 3008729547
- 3013679558
- 3007413079
- 3016618143
- 3007603826
- 3014848734
- 3012528160
- 3003832357
- 3015181391
- 3007048291
- 3010536822
- 3007836437
- 3010703925
- 3015328411
- 9710654
- 3001570235
- 3004415095
- 3010317211
- 9610816
- 3016931915
- 3003263092
- 3000126629
- 3011353843
- 3012494290
- 3003971136
- 9610105
- 3021559257
- 3019388613
- 3003800159
- 3003589956
- 3029871637
- 3005783425
- 3012104670
- 3004977335
- 3011790297
- 1219324
- 3030154814
- 3017760831
- 3010698831
- 3013596024
- 3043479346
- 3023272766
- 3017422354
- 1651104
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- 3016674095
- 3021343210
- 1319390
- 1062836
- 3009499478
- 1220908
- 3008717264
- 3017812398
- 3012359877
- 3014541700
- 3016852448
- 3007305624
- 3009831876
- 9611252
- 1527715
- 3031158
- 3014739036
- 3038259592
- 3009607734
- 1000122786
- 3015876
- 9681377
Source Documents
510(k) summary PDF not indicated by FDA
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Legacy Summary
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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