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510(k) K955535

LOUISVILLE LABS OXYGEN HEAD TENT by Louisville Laboratories, Inc. — Product Code CBF

K955535 is an FDA 510(k) premarket notification submitted by Louisville Laboratories, Inc. for the device "LOUISVILLE LABS OXYGEN HEAD TENT". The FDA issued a decision of Substantially Equivalent on July 1, 1996. The device falls under product code CBF (Chamber, Hyperbaric), a Class II device regulated under 21 CFR 868.5470. Louisville Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1996
Date Received
December 5, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Hyperbaric
Device Class
Class II
Regulation Number
868.5470
Review Panel
AN
Submission Type

Other clearances by Louisville Laboratories, Inc.

  • K980123 — CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET (March 9, 1998)
  • K971796 — LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS (August 12, 1997)
  • K971791 — VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION (July 30, 1997)
  • K971802 — VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION (July 30, 1997)
  • K971801 — LAPAROTOMY BLADDER NECK SUSPENSION KIT (July 22, 1997)
  • K971797 — LAPAROSCOPIC BLADDER NECK SUSPENSION KIT (July 22, 1997)
  • K963076 — LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY (April 4, 1997)
  • K960882 — CONTROL SYRINGE (July 8, 1996)
  • K946282 — UNIVERSAL URETHRAL CATHETER (March 31, 1995)
  • K932979 — EXTERNAL STABILITY PAD (November 2, 1993)

Other clearances for product code CBF

  • K240569 — FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber (November 21, 2024)
  • K220290 — Revitalair 430+ (May 4, 2023)
  • K171899 — Revitalair 430F (November 22, 2019)
  • K163109 — OxyHeal 4000 Multiplace Hyperbaric Chamber Family (March 22, 2017)
  • K152223 — Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen (April 29, 2016)
  • K140559 — SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER (May 30, 2014)
  • K102831 — RSI 4200 (August 19, 2011)
  • K092991 — O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) (August 13, 2010)
  • K101262 — FLEXI-LITE (June 10, 2010)
  • K100268 — SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER (April 26, 2010)

FDA data resources