MODEL LP-1000 VOLUME VENTILATOR— 510(k) K952880

Name: FDA 510(k) clearance K952880
Creator: U.S. Food and Drug Administration
Published: 1996-06-20

Substantially Equivalent - Subject to Tracking Reg.

Aequitron Medical, Inc.

FDA 510(k) clearance K952880 for MODEL LP-1000 VOLUME VENTILATOR, Substantially Equivalent - Subject to Tracking Reg. on 1996-06-20. Applicant: Aequitron Medical, Inc.. Device class: 2.

Clearance details

Applicant: Aequitron Medical, Inc.
Product code: Code CBK
Device class: Class 2
Regulation: 21 CFR 868.5895
Advisory panel: Anesthesiology
Date received: 1995-06-22
Decision date: 1996-06-20
Decision: Substantially Equivalent - Subject to Tracking Reg.
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CBK

view all

K253647 — Evita (V800); Evita (V600)2026-05-07
K252663 — Inbentus Versatile2026-04-14
K251888 — VPAP Pediatric Face Mask2026-03-12
K232365 — Vivo 45 LS2025-12-19
K252173 — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A) +3 more2025-09-10

More clearances from Aequitron Medical, Inc.

view all

K961972 — MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR1997-04-18
K944654 — OXYGEN CONCENTRATION INDICATOR1994-11-08
K914424 — MODEL 6213 REMOTE ALARM1992-09-10
K915381 — PORTABLE OXYGEN GENERATOR1992-03-11
K911399 — NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST)1991-09-19

Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.