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)

HFG 350, 650, 1050

K-Number: K923455 · 1992-12-28

ApplicantVarian Canada, Inc.
Decision Date1992-12-28
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HFG 350, 650, 1050 is the device name listed in this FDA 510(k) record. The listed applicant is Varian Canada, Inc.. It received FDA 510(k) clearance on 1992-12-28 under 510(k) number K923455. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HFG 350, 650, 1050?

HFG 350, 650, 1050 is a medical device that received FDA 510(k) clearance on 1992-12-28. The listed applicant is Varian Canada, Inc.. The 510(k) number is K923455.

When did HFG 350, 650, 1050 receive FDA 510(k) clearance?

HFG 350, 650, 1050 received FDA 510(k) clearance on 1992-12-28, under 510(k) number K923455.

Who is the listed applicant for HFG 350, 650, 1050?

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

What is the FDA product code for HFG 350, 650, 1050?

The FDA product code for HFG 350, 650, 1050 is KPR.

Other records listing Varian Canada, 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.

K953582HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATORK920938VJW2919 PNEUMATIC COMPRESSION UPGRADEK913234VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLYK910820VPW 2877E6 X-RAY POWER SUPPLYK904169VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLYK905855VPW2877E7 X RAY POWER SUPPLY

View all 7 devices →

Related Devices (Code: KPR)

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.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

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.

↑