Question 1

Who is the manufacturer of PRESSURE, LOW/HIGH MODEL C1070?

Accepted Answer

Timeter Instrument Corp. filed the 510(k) submission for PRESSURE, LOW/HIGH MODEL C1070 (K781697).

Question 2

What is the FDA product code for PRESSURE, LOW/HIGH MODEL C1070?

Accepted Answer

CAP. It is classified under 21 CFR 868.2600 as a Class 2 device in the Anesthesiology panel.

Question 3

When was PRESSURE, LOW/HIGH MODEL C1070 cleared by the FDA?

Accepted Answer

Oct 27, 1978 (decision: SESE).

Question 4

What is the regulatory pathway for PRESSURE, LOW/HIGH MODEL C1070?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like PRESSURE, LOW/HIGH MODEL C1070?

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	K781697
Device Name	PRESSURE, LOW/HIGH MODEL C1070
Applicant	Timeter Instrument Corp.
Product Code	CAP · Anesthesiology
Decision Date	Oct 27, 1978
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2600
Device Class	Class 2

PRESSURE, LOW/HIGH MODEL C1070

Device Facts

Regulatory Classification

Identification