FDA 510(k)

ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222

K-Number: K042005 · 2004-08-27

Decision Date2004-08-27

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222 is the device name listed in this FDA 510(k) record. The listed applicant is Taidoc Technology Corporation. It received FDA 510(k) clearance on 2004-08-27 under 510(k) number K042005. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222?

ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222 is a medical device that received FDA 510(k) clearance on 2004-08-27. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K042005.

When did ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222 receive FDA 510(k) clearance?

ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222 received FDA 510(k) clearance on 2004-08-27, under 510(k) number K042005.

Who is the listed applicant for ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222?

The FDA 510(k) record lists Taidoc Technology Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222?

The FDA product code for ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222 is NBW. This falls under the OB/GYN category.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Taidoc Technology Corporation as applicant

K221349XPER Technology PREMIUM Pro Blood Glucose Monitoring System K201037FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System K200946Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)K190579TD-4183 Blood Glucose Monitoring System K182934FORA P100 Blood Pressure Monitoring System K180863FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator

View all 121 devices →

Related Devices (Code: NBW)

K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care K262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc.K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring SystemACON Laboratories, Inc.K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd.K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation K240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd.

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.