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510(k) K801518

SPAN-AID BRIDGING PILLOW SYSTEM by Span-America Medical Systems, Inc. — Product Code HKX

K801518 is an FDA 510(k) premarket notification submitted by Span-America Medical Systems, Inc. for the device "SPAN-AID BRIDGING PILLOW SYSTEM". The FDA issued a decision of Substantially Equivalent on August 4, 1980. The device falls under product code HKX (Tonometer, Ac-Powered), a Class II device regulated under 21 CFR 886.1930. Span-America Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1980
Date Received
July 1, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tonometer, Ac-Powered
Device Class
Class II
Regulation Number
886.1930
Review Panel
OP
Submission Type

Other clearances by Span-America Medical Systems, Inc.

  • K973169 — PRESSURE GUARD SITE SELECT (A) (February 20, 1998)
  • K972486 — PRESSUREGUARD IV (February 20, 1998)
  • K960188 — PRESSUREGUARD: SELECTCARE (October 2, 1996)
  • K961502 — LUBRICATING JELLY, LOW VISCOSITY (July 18, 1996)
  • K961159 — POWERED LOW AIR LOSS MATTRESS SYSTEM (June 14, 1996)
  • K960620 — PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM (April 25, 1996)
  • K960189 — GEL-T CUSHION (February 7, 1996)
  • K954766 — PRESSURE GUARD ALTERNATING PRESSURE MATTRESS (January 11, 1996)
  • K953503 — PRESSUREGUARD IV (October 24, 1995)
  • K954117 — CUSTOMCARE SEATING SYSTEM (October 13, 1995)

Other clearances for product code HKX

  • K253039 — AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA (November 7, 2025)
  • K223739 — VS Tabletop Tonometer (November 8, 2023)
  • K190382 — Intraocular Pressure Tonometer EASYTON (December 6, 2019)
  • K181260 — MiiS Horus Scope DPT 100 (June 21, 2019)
  • K181143 — Keeler TonoCare Tonometer (February 8, 2019)
  • K180820 — Tono Vue Non-Contact Tonometer (December 14, 2018)
  • K162067 — VX130 Ophthalmic Diagnostic Device (April 24, 2017)
  • K143086 — VX120 Ophthalmic Diagnostic Device (June 1, 2015)
  • K113066 — CORVIS ST (November 8, 2012)
  • K111710 — FULL AUTO TONOMETER MODEL TX-20 (September 20, 2011)

FDA data resources