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FDA 510(k)

SALTER LABS INFANT MEDIUM CONCENTRATION MASK

K-Number: K912633 · 1991-07-19

ApplicantSalter Labs
Decision Date1991-07-19
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SALTER LABS INFANT MEDIUM CONCENTRATION MASK is the device name listed in this FDA 510(k) record. The listed applicant is Salter Labs. It received FDA 510(k) clearance on 1991-07-19 under 510(k) number K912633. The device is classified under product code BYG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SALTER LABS INFANT MEDIUM CONCENTRATION MASK?

SALTER LABS INFANT MEDIUM CONCENTRATION MASK is a medical device that received FDA 510(k) clearance on 1991-07-19. The listed applicant is Salter Labs. The 510(k) number is K912633.

When did SALTER LABS INFANT MEDIUM CONCENTRATION MASK receive FDA 510(k) clearance?

SALTER LABS INFANT MEDIUM CONCENTRATION MASK received FDA 510(k) clearance on 1991-07-19, under 510(k) number K912633.

Who is the listed applicant for SALTER LABS INFANT MEDIUM CONCENTRATION MASK?

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 SALTER LABS INFANT MEDIUM CONCENTRATION MASK?

The FDA product code for SALTER LABS INFANT MEDIUM CONCENTRATION MASK is BYG.

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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

View all 47 devices →

Related Devices (Code: BYG)

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.

K963298FIRST AID KIT(S)Vector, Inc.K962848HANS RUDOLPH NASAL CPAP MASKHans Rudolph, Inc.K945482DISPOSABLE, CPAP OXYGEN MASKFvtnksK953464WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASKWestmed, Inc.K953039VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKSDadsun Corp., Ltd.K945472WESTMED PEDIATRIC AND ADULT AEROSOL MASKWestmed Intl.

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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