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FDA 510(k)

GOULD-STATHAM SP1405 PRESSURE MONITOR

K-Number: K780798 · 1978-06-13

ApplicantGould, Inc.
Decision Date1978-06-13
Product CodeDSK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GOULD-STATHAM SP1405 PRESSURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Gould, Inc.. It received FDA 510(k) clearance on 1978-06-13 under 510(k) number K780798. The device is classified under product code DSK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOULD-STATHAM SP1405 PRESSURE MONITOR?

GOULD-STATHAM SP1405 PRESSURE MONITOR is a medical device that received FDA 510(k) clearance on 1978-06-13. The listed applicant is Gould, Inc.. The 510(k) number is K780798.

When did GOULD-STATHAM SP1405 PRESSURE MONITOR receive FDA 510(k) clearance?

GOULD-STATHAM SP1405 PRESSURE MONITOR received FDA 510(k) clearance on 1978-06-13, under 510(k) number K780798.

Who is the listed applicant for GOULD-STATHAM SP1405 PRESSURE MONITOR?

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 GOULD-STATHAM SP1405 PRESSURE MONITOR?

The FDA product code for GOULD-STATHAM SP1405 PRESSURE MONITOR is DSK.

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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: DSK)

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.

K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLCK160945Endophys Blood Pressure MonitorEndophys Holdings, LLCK080670MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor MedicalK070795SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor Medical Pty, Ltd.K033738MONITORING SYSTEM, MODEL ARGUS PB-2200Schiller AGK021517ABP FOR WINDOWSRozinn Electronics, 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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