FDA 510(k)

Fundus On Phone Non Mydriatic (FOP NM-10)

Numéro K : K252120 · 2025-12-12

DemandeurRemidio Innovative Solutions Private Limited

Date de décision2025-12-12

Code produitHKI

Comité consultatifOP

DécisionSubstantially Equivalent

Résumé du dispositif

Fundus On Phone Non Mydriatic (FOP NM-10) is the device name listed in this FDA 510(k) record. The listed applicant is Remidio Innovative Solutions Private Limited. It received FDA 510(k) clearance on 2025-12-12 under 510(k) number K252120. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Fundus On Phone Non Mydriatic (FOP NM-10)?

Fundus On Phone Non Mydriatic (FOP NM-10) is a medical device that received FDA 510(k) clearance on 2025-12-12. The listed applicant is Remidio Innovative Solutions Private Limited. The 510(k) number is K252120.

When did Fundus On Phone Non Mydriatic (FOP NM-10) receive FDA 510(k) clearance?

Fundus On Phone Non Mydriatic (FOP NM-10) received FDA 510(k) clearance on 2025-12-12, under 510(k) number K252120.

Who is the listed applicant for Fundus On Phone Non Mydriatic (FOP NM-10)?

The FDA 510(k) record lists Remidio Innovative Solutions Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fundus On Phone Non Mydriatic (FOP NM-10)?

The FDA product code for Fundus On Phone Non Mydriatic (FOP NM-10) is HKI.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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

Dispositifs connexes (Code : HKI)

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom Technologies K250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.Ltd K250683Resolve Fundus CameraOptain Health, Inc.K243664Sentinel CameraAi Optics

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.