Question 1

Who is the manufacturer of SYSTEM 1085 BODY PLETHYSMOGRAPH?

Accepted Answer

Medical Graphics Corp. filed the 510(k) submission for SYSTEM 1085 BODY PLETHYSMOGRAPH (K852088).

Question 2

What is the FDA product code for SYSTEM 1085 BODY PLETHYSMOGRAPH?

Accepted Answer

CCM. It is classified under 21 CFR 868.1750 as a Class 2 device in the Anesthesiology panel.

Question 3

When was SYSTEM 1085 BODY PLETHYSMOGRAPH cleared by the FDA?

Accepted Answer

Jul 30, 1985 (decision: SESE).

Question 4

What is the regulatory pathway for SYSTEM 1085 BODY PLETHYSMOGRAPH?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like SYSTEM 1085 BODY PLETHYSMOGRAPH?

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	K852088
Device Name	SYSTEM 1085 BODY PLETHYSMOGRAPH
Applicant	Medical Graphics Corp.
Product Code	CCM · Anesthesiology
Decision Date	Jul 30, 1985
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1750
Device Class	Class 2

SYSTEM 1085 BODY PLETHYSMOGRAPH

Device Facts

Regulatory Classification

Identification