Atlas FDA

BZM

26 FDA 510(k) clearances · Product code

147 daysmedian time to decision
270 days90th percentile
26clearances measured

FDA profile

Official device name
Calculator, Pulmonary Function Interpretor (Diagnostic)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1900
Medical specialty
Anesthesiology
Flags
Third-party review eligible
Adverse events (MAUDE)
1998: 1 · 1999: 1 · 2004: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
PULMOTRACK 2020 SYSTEM (K102229)Karmelsonix2011-03-04
PERSONAL WHEEZOMETER (K090863)Karmelsonix2009-09-21
WIM-PC, MODEL 1010 (K071955)Karmelsonix2007-11-01
STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM (K012387)Stethographics, Inc.2002-04-23
PULMOTRACK,MODEL 1010 (K980878)Karmel Medical Acoustic Technologies , Ltd.1998-12-28
ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM (K974200)Orca Diagnostics Corp.1998-07-21
CPX, CCM, CATH WITH 15% CO2 (K955432)Medical Graphics Corp.1996-07-01
MEDGRAPHICS EXERCISE CONSULT (K923209)Medical Graphics Corp.1993-03-11
PB100 DIAGNOSTIC SPIROMETER (K911143)Puritan Bennett Corp.1991-11-29
EXERCISE EVALUATION SYSTEM 2010 (K896345)Medical Graphics Corp.1990-01-20
BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS (K880550)Medimicro Systems, Inc.1988-07-25
SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY (K874902)Gomi Medical Instruments1988-06-07
MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM (K871711)Medical Graphics Corp.1987-09-25
EXERSYSTEM(TM) MMC 5000 (K864911)Med Science1987-08-21
SPIROVISION (K864885)Futuremed Div. of Future Impex Corp.1987-01-15
SPIROMETRICS MODEL 2500 FLOWMATE(TM) (K863953)Spirometrics, Inc.1987-01-15
PULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070 (K861929)Medical Graphics Corp.1986-09-26
SUPERSPIRO (K853190)Cdx Corp.1985-09-26
UNIVERSAL COMPUTER INTERFACE SYSTEM (K851706)Vacumetrics, Inc.1985-05-03
PHYSIOLOGICAL ANALYZER CM-710 (K842782)Cybermedic, Inc.1984-08-17
CM-VII PHYSIOLOGIC ANALYZER (K831586)Cybermedic, Inc.1984-03-19
CDX 200 (K820035)Cdx Corp.1982-03-10
PULMONARY LAB AUTOMATION SYSTEM (K801496)Medical Graphics Corp.1980-07-21
CARDIO-PULMONARY EXERCISE STRESS SYSTEM (K801495)Medical Graphics Corp.1980-07-21
CYBER DX 100 (K791229)Cyber Diagnostics1979-07-30
SCREENING COMPUTEO SC-20 (K771371)Cavitron Corp.1977-08-04

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