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Neurovirtual Maxxi RIP Abdomen Interface 3ft

by Neurovirtual USA, Inc.

Neurovirtual Maxxi RIP Abdomen Interface 3ft (SI2121) is a Class II device made by Neurovirtual USA, Inc., cleared under FDA 510(k) K171304 on 24 Jun 2019 and listed in FDA GUDID since 26 Nov 2019 (UDI-DI 00850008393136), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K171304

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850008393136 UDI-DI Date26 Nov 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK171304 Date24 Jun 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K171304 decided 24 Jun 2019 Active
  • FDA GUDID UDI-DI 00850008393136 listed 26 Nov 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K171304
  2. Listed FDA GUDID 00850008393136

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Neurovirtual
Generic name
Polysomnograph
Model / Ref / Catalog
Maxxi RIP Abdomen Interface 3ft, SI2121
Primary DI / UDI-DI
00850008393136
510(k) Number
FDA product code
MNR
GMDN term
Polysomnograph
Device class
Class II
Regulation number
868.2375
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Polysomnograph

Cleared under the same submission (K171304)

and 7 more cleared under K171304

Similar devices in this category

Other devices filed under Polysomnograph.

Other devices from Neurovirtual USA, Inc.

See all devices from Neurovirtual USA, Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)