FDA 510(k)

Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))

Numéro K : K261410 · 2026-07-30

DemandeurSuite 201, National Innovation Centre

Date de décision2026-07-30

Code produitOLO

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) is the device name listed in this FDA 510(k) record. The listed applicant is Suite 201, National Innovation Centre. It received FDA 510(k) clearance on 2026-07-30 under 510(k) number K261410. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))?

Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) is a medical device that received FDA 510(k) clearance on 2026-07-30. The listed applicant is Suite 201, National Innovation Centre. The 510(k) number is K261410.

When did Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) receive FDA 510(k) clearance?

Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) received FDA 510(k) clearance on 2026-07-30, under 510(k) number K261410.

Who is the listed applicant for Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))?

The FDA 510(k) record lists Suite 201, National Innovation Centre as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))?

The FDA product code for Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) is OLO.

Essais cliniques associés

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Source officielle

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