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FDA 510(k)

EOS

K-Number: K071546 · 2007-09-18

ApplicantBiospace Med
Decision Date2007-09-18
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EOS is the device name listed in this FDA 510(k) record. The listed applicant is Biospace Med. It received FDA 510(k) clearance on 2007-09-18 under 510(k) number K071546. 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 EOS?

EOS is a medical device that received FDA 510(k) clearance on 2007-09-18. The listed applicant is Biospace Med. The 510(k) number is K071546.

When did EOS receive FDA 510(k) clearance?

EOS received FDA 510(k) clearance on 2007-09-18, under 510(k) number K071546.

Who is the listed applicant for EOS?

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

What is the FDA product code for EOS?

The FDA product code for EOS is KPR.

Related PubMed Literature

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.

PMID: 42375709Multimodal LLM vs. Human-Measured Features for AI Predictions of Autism in Home Videos.Algorithms ()

Other records listing Biospace Med 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.

K101398STEREOS WORKSTATIONK090050STEREOS WORKSTATIONK080529STEREOS WORKSTATION

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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