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TriplePlay 10-10000-0401

by Dymedix Diagnostics, Inc.

TriplePlay 10-10000-0401 is a polysomnograph (FDA Class II; FDA product code MNR, Ventilatory Effort Recorder) made by Dymedix Diagnostics, Inc., cleared under FDA 510(k) K990321 on 1 Jun 1999 and listed in FDA GUDID since 10 Oct 2016 (UDI-DI 00817377020032), active as of 22 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 22 Oct 2026

Documents

510(k) K990321

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817377020032 UDI-DI Date10 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK990321 Date1 Jun 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K990321 decided 1 Jun 1999 Active
  • FDA GUDID UDI-DI 00817377020032 listed 10 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K990321
  2. Listed FDA GUDID 00817377020032

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TriplePlay
Generic name
Polysomnograph
Model / reference
10-10000-0401
Primary DI / UDI-DI
00817377020032
510(k) Number
FDA product code
MNR
GMDN term
Polysomnograph
Device class
Class II
Regulation number
868.2375
GUDID distribution status
In Commercial Distribution

Related devices

Category: Polysomnograph

Cleared under the same submission (K990321)

and 3 more cleared under K990321

Similar devices in this category

Other devices filed under Polysomnograph.

Other devices from Dymedix Diagnostics, Inc.

See all devices from Dymedix Diagnostics, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)