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OPERA, OPERA eco

by Unimom.Co

510(k) K190810

OPERA, OPERA eco is a Class II device made by Unimom.Co, cleared under FDA 510(k) K190810 on 30 Aug 2019, 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 NumberK190810 Date30 Aug 2019ClearedStatusActive

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  • Withdrawn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
HGX
Device class
Class II
Regulation
21 CFR Part 884.5160
Advisory committee
Obstetrics/Gynecology
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

Cited by

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

Devices cleared under K190810

3 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 K190810
UDI-DISize and differences
Unimom Opera
Unimom.Co
Opera08809224872262 —On the market
Unimom Opera eco
Unimom.Co
Opera eco08809224872279 —On the market
Unimom Opera+
Unimom.Co
Opera+08809224872460 —On the market

Similar devices

Other devices filed under FDA product code HGX (Pump, Breast, Powered).

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