Question 1

Who is the manufacturer of SPIROLOOP, MODIFICATION?

Accepted Answer

Pneumedics, Inc. filed the 510(k) submission for SPIROLOOP, MODIFICATION (K904633).

Question 2

What is the FDA product code for SPIROLOOP, MODIFICATION?

Accepted Answer

CCJ. It is classified under 21 CFR 868.1430 as a Class 2 device in the Anesthesiology panel.

Question 3

When was SPIROLOOP, MODIFICATION cleared by the FDA?

Accepted Answer

Mar 12, 1991 (decision: SESE).

Question 4

What is the regulatory pathway for SPIROLOOP, MODIFICATION?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like SPIROLOOP, MODIFICATION?

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	K904633
Device Name	SPIROLOOP, MODIFICATION
Applicant	Pneumedics, Inc.
Product Code	CCJ · Anesthesiology
Decision Date	Mar 12, 1991
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1430
Device Class	Class 2

SPIROLOOP, MODIFICATION

Device Facts

Regulatory Classification

Identification