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Pressureguard IV

by Span-America Medical Systems, Inc. 4 variants

510(k) K951112

Pressureguard IV is a Class II device made by Span-America Medical Systems, Inc., cleared under FDA 510(k) K951112 on 6 Jun 1995, 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 NumberK951112 Date6 Jun 1995ClearedStatusActive

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  • Withdrawn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
FNM
Device class
Class II
Regulation
21 CFR Part 880.5550
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code FNM (Mattress, Air Flotation, Alternating Pressure).

Other devices from Span-America Medical Systems, Inc.

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