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)

ESPREE' BREATHING CIRCUIT (W/ACCESS

K-Number: K821311 · 1982-05-21

ApplicantEsp Plastics, Inc.
Decision Date1982-05-21
Product CodeCAI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ESPREE' BREATHING CIRCUIT (W/ACCESS is the device name listed in this FDA 510(k) record. The listed applicant is Esp Plastics, Inc.. It received FDA 510(k) clearance on 1982-05-21 under 510(k) number K821311. The device is classified under product code CAI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESPREE' BREATHING CIRCUIT (W/ACCESS?

ESPREE' BREATHING CIRCUIT (W/ACCESS is a medical device that received FDA 510(k) clearance on 1982-05-21. The listed applicant is Esp Plastics, Inc.. The 510(k) number is K821311.

When did ESPREE' BREATHING CIRCUIT (W/ACCESS receive FDA 510(k) clearance?

ESPREE' BREATHING CIRCUIT (W/ACCESS received FDA 510(k) clearance on 1982-05-21, under 510(k) number K821311.

Who is the listed applicant for ESPREE' BREATHING CIRCUIT (W/ACCESS?

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

What is the FDA product code for ESPREE' BREATHING CIRCUIT (W/ACCESS?

The FDA product code for ESPREE' BREATHING CIRCUIT (W/ACCESS is CAI.

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 Esp Plastics, 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.

K821310ESPREE' ANESTHESIA BACTERIAL FILTERK821308ESPREE' GUEDEL ESPREE BERMAN AIRWAYK821309ESPREE', BREATHING BAG

Related Devices (Code: CAI)

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.

K954480CONDENSATE COLLECTION KITNova-VentrxK953787UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUITUnicor, Inc.K953788UNICOR, INC. GAS SAMPLING LINES & CONNECTORSUnicor, Inc.K952016PRIMA PEDIATRIC GAS SAMPLING CIRCUITSPrima, Inc.K952018PRIMA COAXIAL CIRCUITSPrima, Inc.K952020PRIMA PEDIATRIC ANESTHESIA CIRCUITSPrima, 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.

↑