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FDA 510(k)

BES - BREATH EXPOSURE SYNCHRONIZER

K-Number: K942581 · 1994-12-12

ApplicantThe Henry G. Dietz Co., Inc.
Decision Date1994-12-12
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BES - BREATH EXPOSURE SYNCHRONIZER is the device name listed in this FDA 510(k) record. The listed applicant is The Henry G. Dietz Co., Inc.. It received FDA 510(k) clearance on 1994-12-12 under 510(k) number K942581. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BES - BREATH EXPOSURE SYNCHRONIZER?

BES - BREATH EXPOSURE SYNCHRONIZER is a medical device that received FDA 510(k) clearance on 1994-12-12. The listed applicant is The Henry G. Dietz Co., Inc.. The 510(k) number is K942581.

When did BES - BREATH EXPOSURE SYNCHRONIZER receive FDA 510(k) clearance?

BES - BREATH EXPOSURE SYNCHRONIZER received FDA 510(k) clearance on 1994-12-12, under 510(k) number K942581.

Who is the listed applicant for BES - BREATH EXPOSURE SYNCHRONIZER?

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

What is the FDA product code for BES - BREATH EXPOSURE SYNCHRONIZER?

The FDA product code for BES - BREATH EXPOSURE SYNCHRONIZER is KPR.

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Other records listing The Henry G. Dietz Co., 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.

K903504HALA'TUS 1 OXYGENATOR

Related Devices (Code: KPR)

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.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

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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