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)

IBIS II

K-Number: K812963 · 1981-11-24

ApplicantCgr Medical Corp.
Decision Date1981-11-24
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IBIS II is the device name listed in this FDA 510(k) record. The listed applicant is Cgr Medical Corp.. It received FDA 510(k) clearance on 1981-11-24 under 510(k) number K812963. 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 IBIS II?

IBIS II is a medical device that received FDA 510(k) clearance on 1981-11-24. The listed applicant is Cgr Medical Corp.. The 510(k) number is K812963.

When did IBIS II receive FDA 510(k) clearance?

IBIS II received FDA 510(k) clearance on 1981-11-24, under 510(k) number K812963.

Who is the listed applicant for IBIS II?

The FDA 510(k) record lists Cgr Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IBIS II?

The FDA product code for IBIS II is JAA.

Other records listing Cgr Medical Corp. 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.

K843926PRESTILIX 1690K843235STENOSCOPK843985SUSPENSION 7K841649MAXIMAX - 4K833223SONEL 3000AK833941ORION

View all 20 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.

↑