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FDA 510(k)

ACKRAD BRONCHITRAC

K-Number: K822398 · 1982-10-04

ApplicantAckrad Laboratories
Decision Date1982-10-04
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ACKRAD BRONCHITRAC is the device name listed in this FDA 510(k) record. The listed applicant is Ackrad Laboratories. It received FDA 510(k) clearance on 1982-10-04 under 510(k) number K822398. The device is classified under product code BSY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACKRAD BRONCHITRAC?

ACKRAD BRONCHITRAC is a medical device that received FDA 510(k) clearance on 1982-10-04. The listed applicant is Ackrad Laboratories. The 510(k) number is K822398.

When did ACKRAD BRONCHITRAC receive FDA 510(k) clearance?

ACKRAD BRONCHITRAC received FDA 510(k) clearance on 1982-10-04, under 510(k) number K822398.

Who is the listed applicant for ACKRAD BRONCHITRAC?

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

What is the FDA product code for ACKRAD BRONCHITRAC?

The FDA product code for ACKRAD BRONCHITRAC is BSY.

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Other records listing Ackrad Laboratories 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.

K021272SIB CATHETER, MODEL 61-7005K020954H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAYK020951H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007K970492INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETERK961752H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)K940176ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION

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Related Devices (Code: BSY)

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.

K031997MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEMMallinckrodt Dar S.R.L.K992902AMBU HAND POWER SUCTION PUMPAmbu, Inc.K982945DUAL PURPOSE CLOSED CATHETERSpirit Medical Systems, Inc.K981910SUCTION CATHETERNi-Med, Inc.K972258HI-CARE CLOSED SUCTION SYSTEMMallinckrodt MedicalK973199AMSINO SUCTION CATHETERAmsino Intl., 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.

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