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FDA 510(k)

CHALLENGER DOSIMETER

K-Number: K870755 · 1987-03-16

ApplicantSalter Labs
Decision Date1987-03-16
Product CodeCCQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CHALLENGER DOSIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Salter Labs. It received FDA 510(k) clearance on 1987-03-16 under 510(k) number K870755. The device is classified under product code CCQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHALLENGER DOSIMETER?

CHALLENGER DOSIMETER is a medical device that received FDA 510(k) clearance on 1987-03-16. The listed applicant is Salter Labs. The 510(k) number is K870755.

When did CHALLENGER DOSIMETER receive FDA 510(k) clearance?

CHALLENGER DOSIMETER received FDA 510(k) clearance on 1987-03-16, under 510(k) number K870755.

Who is the listed applicant for CHALLENGER DOSIMETER?

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

What is the FDA product code for CHALLENGER DOSIMETER?

The FDA product code for CHALLENGER DOSIMETER is CCQ.

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Other records listing Salter Labs 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.

K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)K161719Salter Labs Bubble HumidifierK151874BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/NasalK151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaK151421Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample LinesK092685PNEUMOTHERML, MODEL: 5800

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Related Devices (Code: CCQ)

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.

K972397EZ SPRAYIntertex Research, Inc.K964956E-Z SPACER MASK (SMALL)Airpharma, LLCK961894MDI TUTORMdi Tutor, Inc.K961455MEDSHIELD/AEROCHAMBERDiemolding Corp.K960593SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100Aradigm Corp.K922033SALINE SOLUTION- STERILETrinity Laboratories, 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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