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FDA 510(k)

WALLABY(TM) BLANKET

K-Number: K883779 · 1988-11-14

ApplicantFiberoptic Medical Products, Inc.
Decision Date1988-11-14
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

WALLABY(TM) BLANKET is the device name listed in this FDA 510(k) record. The listed applicant is Fiberoptic Medical Products, Inc.. It received FDA 510(k) clearance on 1988-11-14 under 510(k) number K883779. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WALLABY(TM) BLANKET?

WALLABY(TM) BLANKET is a medical device that received FDA 510(k) clearance on 1988-11-14. The listed applicant is Fiberoptic Medical Products, Inc.. The 510(k) number is K883779.

When did WALLABY(TM) BLANKET receive FDA 510(k) clearance?

WALLABY(TM) BLANKET received FDA 510(k) clearance on 1988-11-14, under 510(k) number K883779.

Who is the listed applicant for WALLABY(TM) BLANKET?

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

What is the FDA product code for WALLABY(TM) BLANKET?

The FDA product code for WALLABY(TM) BLANKET is LBI.

Related Clinical Trials

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.

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Other records listing Fiberoptic Medical Products, 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.

K944686FIBEROPTIC LARYNGOSCOPE HANDLEK933598ENDOSTAR(TM) STYLETK921393IMAGICA MICRO-ENDOSCOPEK912252INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT

Related Devices (Code: LBI)

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.

K251308SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)Thera B Medical ProductsK243372BiliWrapGerium Medical, Ltd.K210289Infant Phototherapy EquipmentBistos Co., Ltd.K200031Neonatal Phototherapy SystemAvalon Biomedical (Shenzhen) LimitedK190899bili-hutLittle Sparrows Technologies, Inc.K182178neoBLUE blanket LED Phototherapy SystemNatus Medical Incorporated

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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