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O2-Cpap 313-7715

by Pulmodyne Inc.

O2-Cpap 313-7715 is a Class II device made by Pulmodyne Inc., cleared under FDA 510(k) K983920 on 22 Jan 1999 and listed in FDA GUDID since 30 Mar 2018 (UDI-DI 00841470111014), 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) K983920

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 Number00841470111014 UDI-DI Date30 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK983920 Date22 Jan 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K983920 decided 22 Jan 1999 Active
  • FDA GUDID UDI-DI 00841470111014 listed 30 Mar 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K983920
  2. Listed FDA GUDID 00841470111014

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
O2-Cpap
Generic name
PEEP valve, single-use
Model / reference
313-7715
Primary DI / UDI-DI
00841470111014
510(k) Number
FDA product code
BYE
GMDN term
PEEP valve, single-use
Device class
Class II
Regulation number
868.5965
GUDID distribution status
In Commercial Distribution

Related devices

Category: PEEP valve, single-use

Cleared under the same submission (K983920)

and 5 more cleared under K983920

Other devices from Pulmodyne Inc.

See all devices from Pulmodyne Inc. →

Properties

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