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FDA 510(k)

MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP

K-Number: K894667 · 1989-10-19

ApplicantPneumedics, Inc.
Decision Date1989-10-19
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP is the device name listed in this FDA 510(k) record. The listed applicant is Pneumedics, Inc.. It received FDA 510(k) clearance on 1989-10-19 under 510(k) number K894667. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP?

MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP is a medical device that received FDA 510(k) clearance on 1989-10-19. The listed applicant is Pneumedics, Inc.. The 510(k) number is K894667.

When did MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP receive FDA 510(k) clearance?

MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP received FDA 510(k) clearance on 1989-10-19, under 510(k) number K894667.

Who is the listed applicant for MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP?

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

What is the FDA product code for MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP?

The FDA product code for MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP is BTY.

Related Clinical Trials

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Other records listing Pneumedics, 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.

K904633SPIROLOOP, MODIFICATIONK863087SPIROLOOP-PULMONARY EXERCISE SYSTEM

Related Devices (Code: BTY)

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.

K260242CPETWise PlatformMedibyt , Ltd.K242809Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics CorporationK223629SpiroSphere, SpiroSphereECG, CardioSphereEresearchtechnology GmbHK231561Pulmonary Function Tester, Model: A9Guangzhou Homesun Medical Technology Co., Ltd.K222982Virtus Metabolic MonitorVirtus Technology ApsK221030Model 9100 PFT/DICOVitalograph Ireland, Ltd.

Official Source

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

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