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)

ARC-600

K-Number: K933100 · 1993-11-08

ApplicantB C Medical , Ltd.
Decision Date1993-11-08
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ARC-600 is the device name listed in this FDA 510(k) record. The listed applicant is B C Medical , Ltd.. It received FDA 510(k) clearance on 1993-11-08 under 510(k) number K933100. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARC-600?

ARC-600 is a medical device that received FDA 510(k) clearance on 1993-11-08. The listed applicant is B C Medical , Ltd.. The 510(k) number is K933100.

When did ARC-600 receive FDA 510(k) clearance?

ARC-600 received FDA 510(k) clearance on 1993-11-08, under 510(k) number K933100.

Who is the listed applicant for ARC-600?

The FDA 510(k) record lists B C Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARC-600?

The FDA product code for ARC-600 is JAA.

Other records listing B C Medical , Ltd. 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.

K946378BCM 400CPK933035BCM-600TXK920862BCM-400CK890306BCM-ARC 105 X-RAY MOBILE UNITK870205ROTAX-II BI-PLANE CIRCULAR ARMK801950BCM-600 MINI-SIX EXTRA LG. FIELD ANGIO

View all 8 devices →

Related Devices (Code: JAA)

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.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

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.

↑