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FDA 510(k)

BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID.

K-Number: K915786 · 1992-06-30

ApplicantHelix Medical, Inc.
Decision Date1992-06-30
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID. is the device name listed in this FDA 510(k) record. The listed applicant is Helix Medical, Inc.. It received FDA 510(k) clearance on 1992-06-30 under 510(k) number K915786. The device is classified under product code BYD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID.?

BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID. is a medical device that received FDA 510(k) clearance on 1992-06-30. The listed applicant is Helix Medical, Inc.. The 510(k) number is K915786.

When did BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID. receive FDA 510(k) clearance?

BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID. received FDA 510(k) clearance on 1992-06-30, under 510(k) number K915786.

Who is the listed applicant for BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID.?

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

What is the FDA product code for BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID.?

The FDA product code for BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID. is BYD.

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Other records listing Helix Medical, 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.

K023259INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200K991587BLOM-SINGER INDWELLING 2000 VOICE PROSTHESISK945287INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICEK945288INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICEK932120BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHESK932163BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET

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Related Devices (Code: BYD)

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.

K955008HEAT & MOISTURE EXCHANGERIntertech Resources, Inc.K954194DISPOSABLE HME/FILTEREngstrom MedicalK953580HEAT MOISTURE EXCHANGERIntertech Resources, Inc.K953507TYPE 1 & 2 (HUMIDAIR I & II)Icor ABK953544HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHTGibeck, Inc.K953620WARM N WET HMEF W/LUER ADAPTERHospitak, 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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