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Aurora

by Ensodata, Inc.

510(k) K231355

Aurora is a Class II device made by Ensodata, Inc., cleared under FDA 510(k) K231355 on 9 Feb 2024, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK231355 Date9 Feb 2024ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MNR
FDA applicant
Ensodata
Device class
Class II
Regulation
21 CFR Part 868.2375
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K231355

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K231355
UDI-DISize and differences
EnsoSleep PPG 7.0
Ensodata, Inc.
7.000864458000445
Prescription: no
No longer on the market
EnsoSleep PPG 8
Ensodata, Inc.
800864458000469
Prescription: yes
On the market

Similar devices

Other devices filed under FDA product code MNR (Ventilatory Effort Recorder).

Other devices from Ensodata, Inc.

  • Celeste+ 8

    Class II

  • EnsoSleep 8

    Class II

  • EnsoSleep PPG 8

    Class II

  • EnsoSleep

    Class II

See all devices from Ensodata, Inc. →