FDA 510(k)

SAPPHIRE, ELEVARE SAPPHIRE

Número K: K172555 · 2018-05-01

RequerenteOmm Imports, Inc. D/B/A Zero Gravity

Data da decisão2018-05-01

Código do produtoOLP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

SAPPHIRE, ELEVARE SAPPHIRE is the device name listed in this FDA 510(k) record. The listed applicant is Omm Imports, Inc. D/B/A Zero Gravity. It received FDA 510(k) clearance on 2018-05-01 under 510(k) number K172555. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SAPPHIRE, ELEVARE SAPPHIRE?

SAPPHIRE, ELEVARE SAPPHIRE is a medical device that received FDA 510(k) clearance on 2018-05-01. The listed applicant is Omm Imports, Inc. D/B/A Zero Gravity. The 510(k) number is K172555.

When did SAPPHIRE, ELEVARE SAPPHIRE receive FDA 510(k) clearance?

SAPPHIRE, ELEVARE SAPPHIRE received FDA 510(k) clearance on 2018-05-01, under 510(k) number K172555.

Who is the listed applicant for SAPPHIRE, ELEVARE SAPPHIRE?

The FDA 510(k) record lists Omm Imports, Inc. D/B/A Zero Gravity as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAPPHIRE, ELEVARE SAPPHIRE?

The FDA product code for SAPPHIRE, ELEVARE SAPPHIRE is OLP.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Omm Imports, Inc. D/B/A Zero Gravity como candidato(a)

K183329Laser Hair Therapy

Dispositivos Relacionados (Código: OLP)

K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.K251843Erchonia EVRLErchonia Corporation K242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,Ltd K243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INTDongguan Hunter Electronic Technology Co., Ltd.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.