Atlas FDA

D.C. AMPLIFIER MODULE

FDA 510(k) clearance K770247 · decided 1977-02-14

Clearance details

K-number
K770247
Device name
D.C. AMPLIFIER MODULE
Applicant
Mennen Greatbatch Electonics
Decision
Substantially Equivalent
Date received
1977-02-07
Decision date
1977-02-14
Days to decision
7 days
Clearance type
Traditional
Product code
DRQ
Device class
2
Regulation number
870.2060
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Mennen Greatbatch Electonics

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ACIST RXi Mini System (K172216)Acist Medical Systems, Inc.2017-08-18
CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels (K152693)Boston Scientific Corporation2015-10-21
CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels (K150235)Boston Scientific Corporation2015-04-22
BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO (K050006)C.R. Bard, Inc.2005-05-27
DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS (K050974)Draeger Medical Systems, Inc.2005-04-29
INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER (K033807)Draeger Medical Systems, Inc.2004-03-09
MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 (K013205)Millar Instruments, Inc.2002-07-02
SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER (K020277)Siemens Medical Solutions USA, Inc.2002-02-19
SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER (K010640)Siemens Medical Solutions USA, Inc.2001-03-20
BARD(R) BIOPOTENTIAL AMPLIFIER II (K913875)Bard Electrophysiology1991-11-27
PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED (K913110)Microwave Medical Systems, Inc.1991-10-10
SFA-II MICROPROCESSOR-CONTROLLED MODULE (K910905)Life Sciences Manufacturing, Inc.1991-07-24

Recalls involving this device

No recalls on record reference this clearance.