Cleared Special

HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02

K982619 · Hewlett-Packard Co. · Anesthesiology
Aug 1998
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K982619 is an FDA 510(k) clearance for the HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02, a Analyzer, Gas, Oxygen, Gaseous-phase (Class II — Special Controls, product code CCL), submitted by Hewlett-Packard Co. (Andover, US). The FDA issued a Cleared decision on August 12, 1998, 16 days after receiving the submission on July 27, 1998. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1720.

Submission Details

510(k) Number K982619 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 1998
Decision Date August 12, 1998
Days to Decision 16 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CCL — Analyzer, Gas, Oxygen, Gaseous-phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1720

More from Hewlett-Packard Co.

View all
HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE
K992543 · MKJ · May 2000
HP M2376A DEVICE LINK SYSTEM
K993587 · MQS · Jan 2000
MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A
K993169 · DRG · Dec 1999
HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A
K992977 · MKJ · Dec 1999
HP M2600A VIRIDIA TELEMETRY SYSTEM
K993516 · DSI · Nov 1999