Question 1

Who is the manufacturer of PEDIATRIC ANESTHESIA CIRCUITS?

Accepted Answer

Med-Plastics Intl., Inc. filed the 510(k) submission for PEDIATRIC ANESTHESIA CIRCUITS (K932580).

Question 2

What is the FDA product code for PEDIATRIC ANESTHESIA CIRCUITS?

Accepted Answer

CAI. It is classified under 21 CFR 868.5240 as a Class 1 device in the Anesthesiology panel.

Question 3

When was PEDIATRIC ANESTHESIA CIRCUITS cleared by the FDA?

Accepted Answer

Jul 16, 1993 (decision: SESE).

Question 4

What is the regulatory pathway for PEDIATRIC ANESTHESIA CIRCUITS?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like PEDIATRIC ANESTHESIA CIRCUITS?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K932580
Device Name	PEDIATRIC ANESTHESIA CIRCUITS
Applicant	Med-Plastics Intl., Inc.
Product Code	CAI · Anesthesiology
Decision Date	Jul 16, 1993
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5240
Device Class	Class 1

PEDIATRIC ANESTHESIA CIRCUITS

Device Facts

Regulatory Classification

Identification