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Mdf® MDF808B08

by MDF Instruments Medifriend Inc.

Mdf® MDF808B08 is a Class II device made by MDF Instruments Medifriend Inc., cleared under FDA 510(k) K950778 on 14 Mar 1995 and listed in FDA GUDID since 31 Dec 2018 (UDI-DI 06940211628027), active as of 9 Nov 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 9 Nov 2026

Documents

510(k) K950778

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06940211628027 UDI-DI Date31 Dec 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK950778 Date14 Mar 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K950778 decided 14 Mar 1995 Active
  • FDA GUDID UDI-DI 06940211628027 listed 31 Dec 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K950778
  2. Listed FDA GUDID 06940211628027

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mdf®
Generic name
Aneroid manual sphygmomanometer
Model / reference
MDF808B08
Description
Aneroid Sphygmomanometer, Double Bellow, MDF08
Primary DI / UDI-DI
06940211628027
510(k) Number
FDA product code
DXQ
GMDN term
Aneroid manual sphygmomanometer
Device class
Class II
Regulation number
870.1120
GUDID distribution status
In Commercial Distribution

Other devices from MDF Instruments Medifriend Inc.

See all devices from MDF Instruments Medifriend Inc. →

Properties

  • Over-the-counter
  • Convenience kit
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)