Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TP 1

K-Number: K844483 · 1985-04-19

ApplicantVitatron Medical BV
Decision Date1985-04-19
Product CodeKRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TP 1 is the device name listed in this FDA 510(k) record. The listed applicant is Vitatron Medical BV. It received FDA 510(k) clearance on 1985-04-19 under 510(k) number K844483. The device is classified under product code KRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TP 1?

TP 1 is a medical device that received FDA 510(k) clearance on 1985-04-19. The listed applicant is Vitatron Medical BV. The 510(k) number is K844483.

When did TP 1 receive FDA 510(k) clearance?

TP 1 received FDA 510(k) clearance on 1985-04-19, under 510(k) number K844483.

Who is the listed applicant for TP 1?

The FDA 510(k) record lists Vitatron Medical BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TP 1?

The FDA product code for TP 1 is KRG.

Other records listing Vitatron Medical BV 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.

K854790CERYX PACEMAKER MODELS 114, 314 & 614K844484HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEAK844485CERYX6, 611, CERYX 3 311 & CERYX 1 111K840668ELECTRODE PACEMAKER, PERM & TEMPK831859PACEMAKER PROGRAMMER #2032K831860GENERATOR, PULSE, PACEMAKER #532

View all 19 devices →

Related Devices (Code: KRG)

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.

K933278INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04Intermedics, Inc.K884522MODEL 5650 OPTIMATE PERSONAL PROGRAMMERTeletronics, Inc.K880738MODEL 2331T PATIENT PROGRAMMERMedtronic VascularK882429MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004Tpl-Cordis, Inc.K864712MODEL 1740 PERSONAL POCKET PROGRAMMERTelectronics, Inc.K871986MODEL 5600B PROGRAMMER, PACEMAKERTelectronics, 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.

↑