HME-10 (TM)— 510(k) K903054

Substantially Equivalent

Pharma Systems, Inc.

FDA 510(k) clearance K903054 for HME-10 (TM), Substantially Equivalent on 1990-10-31. Applicant: Pharma Systems, Inc.. Device class: 1.

Clearance details

Applicant: Pharma Systems, Inc.
Product code: Code BYD
Device class: Class 1
Regulation: 21 CFR 868.5375
Advisory panel: Anesthesiology
Date received: 1990-07-11
Decision date: 1990-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bernardsville, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BYD

K955008 — HEAT & MOISTURE EXCHANGER1996-01-30
K954194 — DISPOSABLE HME/FILTER1995-10-20
K953580 — HEAT MOISTURE EXCHANGER1995-09-15
K953507 — TYPE 1 & 2 (HUMIDAIR I & II)1995-09-07
K953491 — HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE1995-08-25

More clearances from Pharma Systems, Inc.

K903057 — FREEVENT (TM)1990-11-20
K903055 — EXTENDED LIFE CIRCUITS1990-11-09
K903058 — BACT-HME (TM)1990-11-09
K903056 — BACTTRAP1990-11-05

Recalls naming K903054

K-number listed on FDA's recall record

Z-1596-2015 — ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.Class III·Terminated·Arc Medical Inc·20150219

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K903054.

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