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micromed BRAIN SPY PLUS

by Micromed, Inc.

micromed BRAIN SPY PLUS is a Class II device made by Micromed, Inc., cleared under FDA 510(k) K071782 on 10 Jan 2008 and listed in FDA GUDID since 21 Mar 2018 (UDI-DI 08033928120743), 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) K071782

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 Number08033928120743 UDI-DI Date21 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK071782 Date10 Jan 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K071782 decided 10 Jan 2008 Active
  • FDA GUDID UDI-DI 08033928120743 listed 21 Mar 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K071782
  2. Listed FDA GUDID 08033928120743

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
micromed
Generic name
Polysomnograph
Model / reference
BRAIN SPY PLUS
Primary DI / UDI-DI
08033928120743
510(k) Number
FDA product code
OLV
GMDN term
Polysomnograph
Device class
Class II
Regulation number
882.1400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Polysomnograph

Cleared under the same submission (K071782)

and 2 more cleared under K071782

Similar devices in this category

Other devices filed under Polysomnograph.

Other devices from Micromed, Inc.

See all devices from Micromed, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)