Heater Base, Model PMH7000
FDA 510(k) K080149 · Pacific Medico Co., Ltd.
510(k) numberK080149
Submission
- Device name
- Heater Base, Model PMH7000
- Applicant
- Pacific Medico Co., Ltd.
Tokyo, JP - Received
- January 22, 2008
- Decision date
- December 18, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTT – Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5450
- Specialty
- Anesthesiology
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| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…BTT · Traditional | Medline Industries, LP | 07/02/2025SE |
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| K242717 | Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional | Laboratorios Biogalenic S.A. DE C.V. | 01/30/2025SE |
| K241778 | Hudson RCI Comfort Flo® CubCannulaBTT · Traditional | Medline Industries, LP | 12/19/2024SE |
| K240163 | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaBTT · Traditional | Medline Industries, LP | 09/27/2024SE |
More from Medline Industries, LP
| 510(k) | Device | Decision |
|---|---|---|
| K132857 | Respiratory Gas HumidifierBTT · Special | 05/01/2014SE |
Questions and answers
When was Heater Base, Model PMH7000 cleared by the FDA?
Heater Base, Model PMH7000 (K080149) received a 510(k) decision of Substantially Equivalent on December 18, 2008, 331 days after the submission was received.
What is the product code of K080149?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.