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FDA 510(k)

PORTABLE BREAST COMPRESSION DEVICE

K-Number: K003775 · 2001-01-12

ApplicantPem Technologies
Decision Date2001-01-12
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PORTABLE BREAST COMPRESSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Pem Technologies. It received FDA 510(k) clearance on 2001-01-12 under 510(k) number K003775. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTABLE BREAST COMPRESSION DEVICE?

PORTABLE BREAST COMPRESSION DEVICE is a medical device that received FDA 510(k) clearance on 2001-01-12. The listed applicant is Pem Technologies. The 510(k) number is K003775.

When did PORTABLE BREAST COMPRESSION DEVICE receive FDA 510(k) clearance?

PORTABLE BREAST COMPRESSION DEVICE received FDA 510(k) clearance on 2001-01-12, under 510(k) number K003775.

Who is the listed applicant for PORTABLE BREAST COMPRESSION DEVICE?

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

What is the FDA product code for PORTABLE BREAST COMPRESSION DEVICE?

The FDA product code for PORTABLE BREAST COMPRESSION DEVICE is IYX.

Related Clinical Trials

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.

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Other records listing Pem Technologies 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.

K032063PEM 2400 PET SCANNER

Related Devices (Code: IYX)

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.

K230221QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)Versant Medical Physics and Radiation SafetyK2125873D-RD-SRadiopharmaceutical Imaging and Dosimetry, LLCK163687OLINDA EXMHermes Medical Solutions ABK160933Discovery NM 750b BopsyGE HealthcareK162052Sentinella 102, Sentinella 102 HorusGeneral Equipment For Medical Imaging (Oncovision-K123408ERGO IMAGING SYSTEMDigirad Corp.

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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