FDA 510(k)

PAM-RL

K-Number: K010997 · 2001-10-15

ApplicantIndividual Monitoring Systems, Inc.

Decision Date2001-10-15

Product CodeGWQ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

PAM-RL is the device name listed in this FDA 510(k) record. The listed applicant is Individual Monitoring Systems, Inc.. It received FDA 510(k) clearance on 2001-10-15 under 510(k) number K010997. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PAM-RL?

PAM-RL is a medical device that received FDA 510(k) clearance on 2001-10-15. The listed applicant is Individual Monitoring Systems, Inc.. The 510(k) number is K010997.

When did PAM-RL receive FDA 510(k) clearance?

PAM-RL received FDA 510(k) clearance on 2001-10-15, under 510(k) number K010997.

Who is the listed applicant for PAM-RL?

The FDA 510(k) record lists Individual Monitoring Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PAM-RL?

The FDA product code for PAM-RL is GWQ.

Other records listing Individual Monitoring Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K992410ACTITRAC

Related Devices (Code: GWQ)

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity Sas K221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.