Nebulizer

Nebulizer (direct Patient Interface)

Shenzhen Homed Medical Device Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Homed Medical Device Co., Ltd. with the FDA for Nebulizer.

Pre-market Notification Details

• Device ID: K212395
• 510k Number: K212395
• Device Name: Nebulizer
• Classification: Nebulizer (direct Patient Interface)
• Applicant: Shenzhen Homed Medical Device Co., Ltd. 3rd Floor, Block 1, Longquan Industrial Zone, Huarong Road, Dalang Street Shenzhen, CN 518109
• Contact: Shi Shengming
• Correspondent: Shi Shengming; Shenzhen Homed Medical Device Co., Ltd. 3rd Floor, Block 1, Longquan Industrial Zone, Huarong Road, Dalang Street Shenzhen, CN 518109
• Product Code: CAF
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-08-02
• Decision Date: 2022-03-25