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FDA 510(k)

STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT

K-Number: K981167 · 1998-06-18

ApplicantDhd Healthcare Corp.
Decision Date1998-06-18
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT is the device name listed in this FDA 510(k) record. The listed applicant is Dhd Healthcare Corp.. It received FDA 510(k) clearance on 1998-06-18 under 510(k) number K981167. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT?

STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT is a medical device that received FDA 510(k) clearance on 1998-06-18. The listed applicant is Dhd Healthcare Corp.. The 510(k) number is K981167.

When did STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT receive FDA 510(k) clearance?

STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT received FDA 510(k) clearance on 1998-06-18, under 510(k) number K981167.

Who is the listed applicant for STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT?

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

What is the FDA product code for STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT?

The FDA product code for STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT is CAF.

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Other records listing Dhd Healthcare Corp. 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.

K040718TRUSTK002768ACAPELLAK003146CLINIFLO INCENTIVE SPIROMETERK991561ROADRUNNER, PEP THERAPY DEVICEK991300BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICEK983467THERAPEP

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Related Devices (Code: CAF)

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K254171Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)Shenzhen Mericonn Technology Co., Ltd.K260270FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o.K251572eRapid with eTrack SystemPari Respiratory Equipment, Inc.K251659Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd.K244035Portable mesh nebulizer (JM821)Shenzhen Jermei Medical Device Technology Co., Ltd.K243468Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)Joytech Healthcare Co. , Ltd.

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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