Aero Pulse Alternating Pres. Pump
FDA 510(k) K771463 · Medline Industries, Inc.
510(k) numberK771463
Submission
- Device name
- Aero Pulse Alternating Pres. Pump
- Applicant
- Medline Industries, Inc.
Mchenry, IL, US - Received
- August 4, 1977
- Decision date
- August 26, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FNM – Mattress, Air Flotation, Alternating Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5550
- Specialty
- General Hospital
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| K965207 | Rid-Decube IIFNM · Traditional | Skin Care Management, Inc. | 08/21/1997SE |
| K972153 | Alternating Pressure Air Flotation MattressFNM · Traditional | Decubiti Concepts, Inc. | 07/31/1997SE |
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Questions and answers
When was Aero Pulse Alternating Pres. Pump cleared by the FDA?
Aero Pulse Alternating Pres. Pump (K771463) received a 510(k) decision of Substantially Equivalent on August 26, 1977, 22 days after the submission was received.
What is the product code of K771463?
The FDA product code is FNM – Mattress, Air Flotation, Alternating Pressure, a Class II (moderate risk) device regulated under 21 CFR 880.5550.