Monitor Scopes, Models 9502, 9503

Q: What is the product code of K790004?

The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.

FDA 510(k) K790004 · C-V Monitors Corp.

Substantially Equivalent

510(k) numberK790004

Submission

Device name: Monitor Scopes, Models 9502, 9503
Applicant: C-V Monitors Corp.
Mchenry, IL, US
Received: January 2, 1979
Decision date: February 28, 1979
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.2300
Specialty: Cardiovascular

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More from Ivy Biomedical Systems, Inc.

510(k)	Device	Decision
K792099	50MM Writer Model CVM 9529DSF · Traditional	10/26/1979SE
K781867	Writer, GEMINI-3DSF · Traditional	01/05/1979SE
K780572	DCG Preamplifier ModuleDRR · Traditional	05/09/1978SE
K780571	Blood Pressure ModuleDRQ · Traditional	05/09/1978SE

Questions and answers

When was Monitor Scopes, Models 9502, 9503 cleared by the FDA?

Monitor Scopes, Models 9502, 9503 (K790004) received a 510(k) decision of Substantially Equivalent on February 28, 1979, 57 days after the submission was received.

What is the product code of K790004?

The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.