510(k) K150235
- Device
- CLEARSIGN II Amplifier, 40 Channels, CLEARSIGN II Amplifier, 80 Channels, CLEARSIGN II Amplifier, 120 Channels, CLEARSIGN II Amplifer, 160 Channels
- Applicant
- BOSTON SCIENTIFIC CORPORATION
- 510(k) number
- K150235
- Product code
- DRQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-04-22
- Date received
- 2015-02-02
- Regulation
- 870.2060
- Classification name
- Amplifier And Signal Conditioner, Transducer Signal
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MAYLIN TRUESDELL
- Address
- 55 Technology Dr. Lowell MA US 01851 01851
FDA Registration Numbers#
- 3007603826
- 2080783
- 3012528160
- 3013596024
- 3013500228
- 3009156722
- 9610816
- 3014541700
- 3013501110
- 3027605168
- 3011604145
- 3008388260
- 3007481893
- 3013783488
- 3000279201
- 2134243
- 2124215
- 3016701404
- 2032233
- 3009077524
- 3016618143
- 3004977335
- 3007029079
- 1218950
- 9611252
- 3016852448
- 3008729547
- 9681377
- 3010698831
- 3005783425
- 9610105
- 3000126629
- 3003263092
- 2221819
- 3003493679
Source Documents#
Other 510(k) Records For Product Code DRQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172216 | ACIST RXi Mini System | Acist Medical Systems, Inc. | 2017-08-18 |
| K152693 | CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels | Boston Scientific Corporation | 2015-10-21 |
| K050006 | BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO | C.R. Bard, Inc. | 2005-05-27 |
| K050974 | DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS | Draeger Medical Systems, Inc. | 2005-04-29 |
| K033807 | INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER | Draeger Medical Systems, Inc. | 2004-03-09 |
| K013205 | MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 | Millar Instruments, Inc. | 2002-07-02 |
| K020277 | SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER | Siemens Medical Solutions USA, Inc. | 2002-02-19 |
| K010640 | SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER | Siemens Medical Solutions USA, Inc. | 2001-03-20 |
| K913875 | BARD(R) BIOPOTENTIAL AMPLIFIER II | Bard Electrophysiology | 1991-11-27 |
| K913110 | PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED | Microwave Medical Systems, Inc. | 1991-10-10 |
| K910905 | SFA-II MICROPROCESSOR-CONTROLLED MODULE | Life Sciences Manufacturing, Inc. | 1991-07-24 |
| K904749 | TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200 | Transtracheal Systems | 1991-03-01 |
| K901358 | BARD BIOPOTENTIAL AMPLIFIER II | C.R. Bard, Inc. | 1990-05-09 |
| K894295 | ASTRO-MED ASC-951 PRESSURE PROCESSOR | Astro-Med, Inc. | 1990-01-18 |
| K885252 | MAP DC-COUPLED ISOLATED PREAMPLIFIER MODEL #1001 | Ep Technologies, Inc. | 1989-01-13 |
Legacy Summary#
summary
FDA Review#
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