Question 1

Who is the manufacturer of RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18)?

Accepted Answer

Riken Keiki Co., Ltd. filed the 510(k) submission for RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18) (K951366).

Question 2

What is the FDA product code for RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18)?

Accepted Answer

CBS. It is classified under 21 CFR 868.1620 as a Class 2 device in the Anesthesiology panel.

Question 3

When was RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18) cleared by the FDA?

Accepted Answer

Aug 2, 1995 (decision: SESE).

Question 4

What is the regulatory pathway for RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18)?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18)?

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	K951366
Device Name	RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18)
Applicant	Riken Keiki Co., Ltd.
Product Code	CBS · Anesthesiology
Decision Date	Aug 2, 1995
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1620
Device Class	Class 2

RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18)

Device Facts

Regulatory Classification

Identification