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)

RAIN-X

K-Number: K812737 · 1981-10-23

ApplicantNova-Ventrx
Decision Date1981-10-23
Product CodeBZO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RAIN-X is the device name listed in this FDA 510(k) record. The listed applicant is Nova-Ventrx. It received FDA 510(k) clearance on 1981-10-23 under 510(k) number K812737. The device is classified under product code BZO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAIN-X?

RAIN-X is a medical device that received FDA 510(k) clearance on 1981-10-23. The listed applicant is Nova-Ventrx. The 510(k) number is K812737.

When did RAIN-X receive FDA 510(k) clearance?

RAIN-X received FDA 510(k) clearance on 1981-10-23, under 510(k) number K812737.

Who is the listed applicant for RAIN-X?

The FDA 510(k) record lists Nova-Ventrx as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAIN-X?

The FDA product code for RAIN-X is BZO.

Other records listing Nova-Ventrx 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.

K952267CRITERION, CRITERION I.V., MODIFIEDK954480CONDENSATE COLLECTION KITK893760CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004K881207RES-Q 1, 2, 3, 4 AND 5K870382DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011K863756MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT

View all 12 devices →

Related Devices (Code: BZO)

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.

K953784UNICOR, INC. CORRUGATED TUBINGUnicor, Inc.K953785UNICOR, INC. VENTILATOR HOSESUnicor, Inc.K952011PRIMA BREATHING BAGSPrima, Inc.K952022PRIMA VOLUMN VENTILATORSSPrima, Inc.K952010PRIMA VENTILATOR HOSESPrima, Inc.K952012PRIMA CUSTOM ANESTESIA CIRCUITPrima, Inc.

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.

↑