Sofnolime Carbon Dioxide Absorbent

FDA 510(k) K921803 · Molecular Products , Ltd.

Substantially Equivalent

510(k) numberK921803

Submission

Device name
Sofnolime Carbon Dioxide Absorbent
Applicant
Molecular Products , Ltd.
Thaxted, Essex, GB
Received
April 15, 1992
Decision date
October 15, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
CBL – Absorbent, Carbon-Dioxide
Device class
Class I (low risk)
Regulation
21 CFR 868.5300
Specialty
Anesthesiology

Other 510(k)s with product code CBL

510(k)DeviceApplicantDecision
K897171Disposable CO2 Absorber/ECBL · Traditional Gibeck, Inc.03/13/1990SE
K860147Carbon Dioxide AbsorbentsCBL · Traditional Dentsply Intl.02/28/1986SE
K853571Medipart Soda Lime MP-3522CBL · Traditional Medipart Jerry Alexander10/29/1985SE
K811260Baralyme CO2 AbsorbentCBL · Traditional Allied Healthcare Products, Inc.05/27/1981SE

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Questions and answers

When was Sofnolime Carbon Dioxide Absorbent cleared by the FDA?

Sofnolime Carbon Dioxide Absorbent (K921803) received a 510(k) decision of Substantially Equivalent on October 15, 1992, 183 days after the submission was received.

What is the product code of K921803?

The FDA product code is CBL – Absorbent, Carbon-Dioxide, a Class I (low risk) device regulated under 21 CFR 868.5300.