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FDA 510(k)

AUTOMATED NON-INVASIVE PRESSURE MODULE

K-Number: K840909 · 1984-06-15

ApplicantGould, Inc.
Decision Date1984-06-15
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AUTOMATED NON-INVASIVE PRESSURE MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Gould, Inc.. It received FDA 510(k) clearance on 1984-06-15 under 510(k) number K840909. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMATED NON-INVASIVE PRESSURE MODULE?

AUTOMATED NON-INVASIVE PRESSURE MODULE is a medical device that received FDA 510(k) clearance on 1984-06-15. The listed applicant is Gould, Inc.. The 510(k) number is K840909.

When did AUTOMATED NON-INVASIVE PRESSURE MODULE receive FDA 510(k) clearance?

AUTOMATED NON-INVASIVE PRESSURE MODULE received FDA 510(k) clearance on 1984-06-15, under 510(k) number K840909.

Who is the listed applicant for AUTOMATED NON-INVASIVE PRESSURE MODULE?

The FDA 510(k) record lists Gould, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOMATED NON-INVASIVE PRESSURE MODULE?

The FDA product code for AUTOMATED NON-INVASIVE PRESSURE MODULE is DXN.

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Other records listing Gould, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K911935CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIEDK861092MODEL SP1465 CARDIAC OUTPUT COMPUTERK860805PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337K855145MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATORK854403MODEL 2120 SPIROSCREENK851486GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX

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Related Devices (Code: DXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc.K254000Happy Health Blood Pressure MonitorHappy Health, Inc.K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd.K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)JOYTECH Healthcare Co., Ltd.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261061BP Go (BPP-855)Wellvii, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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