I'm getting conflicting information that an ECG extension cable needs a 510k. I always thought that ECG cables required a 510k, but could be based off of a number of predicat devices.

I was told that since the medical deivce this cable connects to has all of the necessary filings, then the ECG extension cable would not require a 510k.

Will someone please clarify?

Thanks!

Application: External defib with an ECG cable. The current configuration is not long enough and requires a extension cable (1:1) to meet the requirements.

I'm getting conflicting information that an ECG extension cable needs a 510k. I always thought that ECG cables required a 510k, but could be based off of a number of predicat devices.

I was told that since the medical deivce this cable connects to has all of the necessary filings, then the ECG extension cable would not require a 510k.

Will someone please clarify?

Thanks!

Application: External defib with an ECG cable. The current configuration is not long enough and requires a extension cable (1:1) to meet the requirements.
It looks like it's exempt. (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm?db=PCD&id=IKD)

It looks like it's exempt. (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm?db=PCD&id=IKD)

Al,

If it's exempt, why are there 3 existing 510(k)s for SE devices?

SE Devices (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/search/search.cfm?Search_Term=890.1175)