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FDA 510(k)

SEP PROGRAMMER SEP-M/SINGLE-PLANE &

K-Number: K840389 · 1984-02-21

ApplicantElema-Schonander, Inc.
Decision Date1984-02-21
Product CodeIZP
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SEP PROGRAMMER SEP-M/SINGLE-PLANE & is the device name listed in this FDA 510(k) record. The listed applicant is Elema-Schonander, Inc.. It received FDA 510(k) clearance on 1984-02-21 under 510(k) number K840389. The device is classified under product code IZP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEP PROGRAMMER SEP-M/SINGLE-PLANE &?

SEP PROGRAMMER SEP-M/SINGLE-PLANE & is a medical device that received FDA 510(k) clearance on 1984-02-21. The listed applicant is Elema-Schonander, Inc.. The 510(k) number is K840389.

When did SEP PROGRAMMER SEP-M/SINGLE-PLANE & receive FDA 510(k) clearance?

SEP PROGRAMMER SEP-M/SINGLE-PLANE & received FDA 510(k) clearance on 1984-02-21, under 510(k) number K840389.

Who is the listed applicant for SEP PROGRAMMER SEP-M/SINGLE-PLANE &?

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

What is the FDA product code for SEP PROGRAMMER SEP-M/SINGLE-PLANE &?

The FDA product code for SEP PROGRAMMER SEP-M/SINGLE-PLANE & is IZP.

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Other records listing Elema-Schonander, 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.

K934944MPQ-42K904103SEP 90K903576PUCK 90MK842911PUCK U & UD CUTFILM CHANGERSK842903SEP PROGRAMMER FOR PUCK U & UD FILMCHANGK790792PULSE GENERATOR MODEL 637

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Related Devices (Code: IZP)

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.

K934944MPQ-42Elema-Schonander, Inc.K911888PHILIPS ANGIOPROPhilips Medical Systems North America, Inc.K904144PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEMMallinckrodt Group, Inc.K904103SEP 90Elema-Schonander, Inc.K874451OMNIPLANE 200 FILM CHANGER SYSTEMMedrad, Inc.K854251THE CSE FILM CHANGER SYSTEMChanger Service & Engineering, 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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