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FDA 510(k)

ROCKING/CIRCULATING CYTO-THERM II 3570

K-Number: K813489 · 1982-03-04

ApplicantCryosan, Inc.
Decision Date1982-03-04
Product CodeKZL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ROCKING/CIRCULATING CYTO-THERM II 3570 is the device name listed in this FDA 510(k) record. The listed applicant is Cryosan, Inc.. It received FDA 510(k) clearance on 1982-03-04 under 510(k) number K813489. The device is classified under product code KZL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCKING/CIRCULATING CYTO-THERM II 3570?

ROCKING/CIRCULATING CYTO-THERM II 3570 is a medical device that received FDA 510(k) clearance on 1982-03-04. The listed applicant is Cryosan, Inc.. The 510(k) number is K813489.

When did ROCKING/CIRCULATING CYTO-THERM II 3570 receive FDA 510(k) clearance?

ROCKING/CIRCULATING CYTO-THERM II 3570 received FDA 510(k) clearance on 1982-03-04, under 510(k) number K813489.

Who is the listed applicant for ROCKING/CIRCULATING CYTO-THERM II 3570?

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 ROCKING/CIRCULATING CYTO-THERM II 3570?

The FDA product code for ROCKING/CIRCULATING CYTO-THERM II 3570 is KZL.

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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 SEPARATORK812309CRYOSAN NORMAL SALINEK812311CIRCULATING CYTO-THERMS

Related Devices (Code: KZL)

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.

K812311CIRCULATING CYTO-THERMSCryosan, Inc.K800699FLO TEM (FLUID WARNER)Chroma Products, Inc.K790936MODEL 114 TREONIC H150 HAEMOHEATERVickers America Medical Corp.

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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