Pneumopulssor (PPS II)

FDA 510(k) K821265 · Strom Corp.

Substantially Equivalent

510(k) numberK821265

Submission

Device name
Pneumopulssor (PPS II)
Applicant
Strom Corp.
Mchenry, IL, US
Received
May 3, 1982
Decision date
July 26, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BYI – Percussor, Powered-Electric
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5665
Specialty
Anesthesiology

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More from Hill-Rom Services Pte, Ltd.

510(k)DeviceDecision
K821570Pneumo Pulssor IIIBYI · Traditional 06/03/1982SE
K813438Pneumo PulssorBYI · Traditional 12/29/1981SE

Questions and answers

When was Pneumopulssor (PPS II) cleared by the FDA?

Pneumopulssor (PPS II) (K821265) received a 510(k) decision of Substantially Equivalent on July 26, 1982, 84 days after the submission was received.

What is the product code of K821265?

The FDA product code is BYI – Percussor, Powered-Electric, a Class II (moderate risk) device regulated under 21 CFR 868.5665.