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)

CRYOSAN NORMAL SALINE

K-Number: K812309 · 1981-09-16

ApplicantCryosan, Inc.
Decision Date1981-09-16
Product CodeGIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CRYOSAN NORMAL SALINE is the device name listed in this FDA 510(k) record. The listed applicant is Cryosan, Inc.. It received FDA 510(k) clearance on 1981-09-16 under 510(k) number K812309. The device is classified under product code GIF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYOSAN NORMAL SALINE?

CRYOSAN NORMAL SALINE is a medical device that received FDA 510(k) clearance on 1981-09-16. The listed applicant is Cryosan, Inc.. The 510(k) number is K812309.

When did CRYOSAN NORMAL SALINE receive FDA 510(k) clearance?

CRYOSAN NORMAL SALINE received FDA 510(k) clearance on 1981-09-16, under 510(k) number K812309.

Who is the listed applicant for CRYOSAN NORMAL SALINE?

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

What is the FDA product code for CRYOSAN NORMAL SALINE?

The FDA product code for CRYOSAN NORMAL SALINE is GIF.

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 Cryosan, 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.

K831953INFUSION PUMPK830831AUTOMATED BLOOD CELL SEPARATORK822521AUTOMATED BLOOD CELL SEPARATORK813489ROCKING/CIRCULATING CYTO-THERM II 3570K812311CIRCULATING CYTO-THERMS

Related Devices (Code: GIF)

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.

K883990KVM ISOTONIC DILUENTKvm Technologies, Inc.K883989KVM ISOTONIC FLUSH SOLUTIONKvm Technologies, Inc.K882490HYCEL QUICK-LYSING HEMOGLOBIN REAGENTR&D Systems, Inc.K882267SYSMEX QUICKLYSER-II (QLS-200A)Toa Medical Electronics USA, Inc.K881130CELL-DYN ISOTONIC DILUENTAbbott DiagnosticsK873347CELL-DYN DIFF. SCREEN ISOTONIC DILUENTAbbott Diagnostics

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.

↑