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FDA 510(k)

SEP 90

K-Number: K904103 · 1990-11-20

ApplicantElema-Schonander, Inc.
Decision Date1990-11-20
Product CodeIZP
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SEP 90 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 1990-11-20 under 510(k) number K904103. 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 90?

SEP 90 is a medical device that received FDA 510(k) clearance on 1990-11-20. The listed applicant is Elema-Schonander, Inc.. The 510(k) number is K904103.

When did SEP 90 receive FDA 510(k) clearance?

SEP 90 received FDA 510(k) clearance on 1990-11-20, under 510(k) number K904103.

Who is the listed applicant for SEP 90?

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 90?

The FDA product code for SEP 90 is IZP.

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-42K903576PUCK 90MK842911PUCK U & UD CUTFILM CHANGERSK842903SEP PROGRAMMER FOR PUCK U & UD FILMCHANGK840389SEP PROGRAMMER SEP-M/SINGLE-PLANE &K790792PULSE GENERATOR MODEL 637

View all 11 devices →

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.K874451OMNIPLANE 200 FILM CHANGER SYSTEMMedrad, Inc.K854251THE CSE FILM CHANGER SYSTEMChanger Service & Engineering, Inc.K842903SEP PROGRAMMER FOR PUCK U & UD FILMCHANGElema-Schonander, 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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