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FDA 510(k)

EMS SWISS ORTHOCLAST

K-Number: K991588 · 1999-07-21

Applicant(Ems Sa) Electro Medical Systems
Decision Date1999-07-21
Product CodeHSZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EMS SWISS ORTHOCLAST is the device name listed in this FDA 510(k) record. The listed applicant is (Ems Sa) Electro Medical Systems. It received FDA 510(k) clearance on 1999-07-21 under 510(k) number K991588. The device is classified under product code HSZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMS SWISS ORTHOCLAST?

EMS SWISS ORTHOCLAST is a medical device that received FDA 510(k) clearance on 1999-07-21. The listed applicant is (Ems Sa) Electro Medical Systems. The 510(k) number is K991588.

When did EMS SWISS ORTHOCLAST receive FDA 510(k) clearance?

EMS SWISS ORTHOCLAST received FDA 510(k) clearance on 1999-07-21, under 510(k) number K991588.

Who is the listed applicant for EMS SWISS ORTHOCLAST?

The FDA 510(k) record lists (Ems Sa) Electro Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMS SWISS ORTHOCLAST?

The FDA product code for EMS SWISS ORTHOCLAST is HSZ.

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 (Ems Sa) Electro Medical Systems 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.

K073284AIR-FLOW MASTER STANDARDK032099SWISS MASTER LIGHTK992504EMS KERMITK991874EMS SURFACE MOUNT SCALER

Related Devices (Code: HSZ)

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.

K972860CURVTEK TSR SYSTEMBiolectron, Inc.K970345ALIGNMENT INSTRUMENTRichard Wolf Medical Instruments Corp.K955084ASPACH 65,000 (MODIFICATION)The Anspach Effort, Inc.K954080SODEM HIGH SPEED SYSTEMSodem Diffusion SAK944590ETHICON DRILL BIT AND DRILL GUIDEETHICON, Inc.K934336SPINALPLANESynvasive Technology, 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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