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)

PUCK U & UD CUTFILM CHANGERS

K-Number: K842911 · 1984-08-21

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

Device Summary

PUCK U & UD CUTFILM CHANGERS 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 K842911. The device is classified under product code KPX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PUCK U & UD CUTFILM CHANGERS?

PUCK U & UD CUTFILM CHANGERS 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 K842911.

When did PUCK U & UD CUTFILM CHANGERS receive FDA 510(k) clearance?

PUCK U & UD CUTFILM CHANGERS received FDA 510(k) clearance on 1984-08-21, under 510(k) number K842911.

Who is the listed applicant for PUCK U & UD CUTFILM CHANGERS?

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 PUCK U & UD CUTFILM CHANGERS?

The FDA product code for PUCK U & UD CUTFILM CHANGERS is KPX.

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 90MK842903SEP PROGRAMMER FOR PUCK U & UD FILMCHANGK840389SEP PROGRAMMER SEP-M/SINGLE-PLANE &K790792PULSE GENERATOR MODEL 637

View all 11 devices →

Related Devices (Code: KPX)

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.

K945635TRANS X-1000Canon USA, Inc.K935157ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBESRegulatory Consultants TO the Medical Device IndusK934850NUCLEAR ASSOCIATES PERSONNEL PROTECTIVE SHIELDSVictoreen, Inc.K933035BCM-600TXB C Medical , Ltd.K925598BUCKYMATIC AUTOMATIC CHEST FILM CHANGERAcoma Medical Imaging, Inc.K924423MWX-7440 HIGH SPEED BUCKYMidwest X-Ray Equipment Co.

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.

↑