Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SEP PROGRAMMER FOR PUCK U & UD FILMCHANG

K-Number: K842903 · 1984-08-21

ApplicantElema-Schonander, Inc.
Decision Date1984-08-21
Product CodeIZP
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SEP PROGRAMMER FOR PUCK U & UD FILMCHANG 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 1984-08-21 under 510(k) number K842903. 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 FOR PUCK U & UD FILMCHANG?

SEP PROGRAMMER FOR PUCK U & UD FILMCHANG is a medical device that received FDA 510(k) clearance on 1984-08-21. The listed applicant is Elema-Schonander, Inc.. The 510(k) number is K842903.

When did SEP PROGRAMMER FOR PUCK U & UD FILMCHANG receive FDA 510(k) clearance?

SEP PROGRAMMER FOR PUCK U & UD FILMCHANG received FDA 510(k) clearance on 1984-08-21, under 510(k) number K842903.

Who is the listed applicant for SEP PROGRAMMER FOR PUCK U & UD FILMCHANG?

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 FOR PUCK U & UD FILMCHANG?

The FDA product code for SEP PROGRAMMER FOR PUCK U & UD FILMCHANG is IZP.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 CHANGERSK840389SEP 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.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.

↑