Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600

K-Number: K991627 · 1999-05-17

ApplicantRespironics, Inc.
Decision Date1999-05-17
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600 is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 1999-05-17 under 510(k) number K991627. 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 3 PHOTOTHERAPY SYSTEM, MODEL 3600?

WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600 is a medical device that received FDA 510(k) clearance on 1999-05-17. The listed applicant is Respironics, Inc.. The 510(k) number is K991627.

When did WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600 receive FDA 510(k) clearance?

WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600 received FDA 510(k) clearance on 1999-05-17, under 510(k) number K991627.

Who is the listed applicant for WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600?

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

What is the FDA product code for WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600?

The FDA product code for WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Respironics, 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.

K261262Altis Full Face MaskK243394AF531 Oro-Nasal SE Face MaskK231313Therapy Mask 3100 NC/SPK210844DreamWear Silicone Pillows MaskK210386Magneto Nasal MaskK202142Sleepware G3

View all 166 devices →

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.

↑