Atlas FDA

DQC

18 FDA 510(k) clearances · Product code

147 daysmedian time to decision
315 days90th percentile
18clearances measured

FDA profile

Official device name
Phonocardiograph
Device class
Class I (low risk)
Regulation
21 CFR 870.2390
Medical specialty
Cardiovascular
Adverse events (MAUDE)
2003: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH (K950537)Cardiophonics, Inc.1996-03-01
LIFE SOUND SENSOR (K952651)Flowscan, Inc.1995-09-19
ACOUSTIC RECORDER (K943726)Technology Applications Assoc., Inc.1994-11-30
PHONOCARDIOGRAPH (K924054)Echo Ultrasound1993-01-22
DYNAMIC SPECTRAL PHONOCARDIOGRAPH (K902185)Reeves Scientific, Inc.1991-03-25
ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE (K900560)Acuson Corp.1990-12-03
PAG MICROPROCESSOR-CONTROLLED MODULE (K900365)Life Sciences Manufacturing, Inc.1990-07-18
MODIFIED DSP100 AMPLIFIER (K873640)Intl. Acoustics, Inc.1987-12-07
ANDRIES PHYSICAL ASSESSMENT COMPUTER (K870545)Andries Tek, Inc.1987-08-14
DSP100 CAROTID PHONOANGIOGRAPHY MODULE (K864429)Intl. Acoustics, Inc.1987-05-12
DSP100 AMPLIFIER (K860814)Intl. Acoustics, Inc.1986-12-05
NON-INVASIVE CLINICAL VASCULAR LAB (K832679)Life Sciences Manufacturing, Inc.1984-01-03
MEDDARS/ULTRA IMAGER PULSE/PHON MODULE (K811626)Honeywell, Inc.1981-07-01
MODEL 100 SPECTRAVIEW (K800655)Edwards Laboratories1980-04-16
NIC-200 VENTRICULAR FUNCTION ANALYZER (K792466)Nicolet Biomedical Instruments1980-01-24
AMPLIFIER, PC-700 (K780116)Burdick Corp.1978-02-24
PULSE/PHONOCARDIOGRAPHY CHANNEL, 144 (K770757)Honeywell, Inc.1977-05-09
PHON/STRESS SYSTEM (#21126A) (K760464)Hewlett-Packard Co.1976-08-30

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Every clearance here is in the API, with alerts when new ones post.