Tennant & Kelman Type II Transducer, Ultrasonic, Obstetric
FDA PMAClass II (US FDA PMA)
Identity
- Trade Name
- TENNANT(TM) & KELMAN(TM) TYPE II FDA PMA
- Generic Name
- Transducer, ultrasonic, obstetric FDA PMA
Identifiers
- PMA Number
- P800016 FDA PMA
- FDA Product Code
- HGL FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 884.2960 FDA PMA
- Regulation Number
- 884.2960 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
- PMA Supplement
- S007 FDA PMA
This device is an ultrasonic transducer for obstetric use, classified as a Class II medical device under FDA regulations. It is designed for imaging fetal development and maternal anatomy during pregnancy, enabling real-time visualization of the fetus and surrounding tissues through high-frequency sound waves. The transducer operates within the parameters of obstetric ultrasound technology, adhering to safety and performance standards for diagnostic imaging.
The Tennant & Kelman Type II is supplied as a reusable device, intended for use in clinical settings such as obstetrics and gynecology departments. It is regulated under FDA PMA (Premarket Approval) and falls under the product code HGL, with a primary application in obstetric ultrasound examinations. Storage and handling must comply with manufacturer guidelines to ensure proper functionality and sterility before each use, though specific sterility claims are not stated in the data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P800016 | Class II | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA PMA P800016 24 fields · synced Sep 18, 2026