FDA 510(k)

TEA HARZ II

K 號：K233502 · 2023-11-01

決定日期2023-11-01

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

TERA HARZ II is the device name listed in this FDA 510(k) record. The listed applicant is Graphy, Inc.. It received FDA 510(k) clearance on 2023-11-01 under 510(k) number K233502. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TERA HARZ II?

TERA HARZ II is a medical device that received FDA 510(k) clearance on 2023-11-01. The listed applicant is Graphy, Inc.. The 510(k) number is K233502.

When did TERA HARZ II receive FDA 510(k) clearance?

TERA HARZ II received FDA 510(k) clearance on 2023-11-01, under 510(k) number K233502.

Who is the listed applicant for TERA HARZ II?

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

What is the FDA product code for TERA HARZ II?

The FDA product code for TERA HARZ II is EBF.

其他以 Graphy, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253681TEERA HARZ 硬質假牙 (THD-C-500)；TEERA HARZ 硬質假牙 (THD-C-1000)；TEERA HARZ 硬質假牙 (THD-LP-500)；TEERA HARZ 硬質假牙 (THD-LP-1000)；TEERA HARZ 硬質假牙 (THD-P-500)；TEERA HARZ 硬質假牙 (THD-P-1000)；TEERA HARZ 硬質假牙 (THD-CP-500)；TEERA HARZ 硬質假牙 (THD-CP-1000)K240597TEA HA ZI CHING CHUAN K223355Tera Harz Clear K222414特瑞哈茲假牙 K202846TEA HA ZI

相關器械（代碼：EBF）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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