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FDA 510(k)

PUCK 90M

K-Number: K903576 · 1990-09-04

ApplicantElema-Schonander, Inc.
Decision Date1990-09-04
Product CodeKPX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PUCK 90M 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 1990-09-04 under 510(k) number K903576. 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 90M?

PUCK 90M is a medical device that received FDA 510(k) clearance on 1990-09-04. The listed applicant is Elema-Schonander, Inc.. The 510(k) number is K903576.

When did PUCK 90M receive FDA 510(k) clearance?

PUCK 90M received FDA 510(k) clearance on 1990-09-04, under 510(k) number K903576.

Who is the listed applicant for PUCK 90M?

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 90M?

The FDA product code for PUCK 90M is KPX.

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 90K842911PUCK 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: 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.

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