510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PMKClass I

Cpr Aid Device Without Feedback

21 CFR 870.5210 / Cardiovascular
FDA source (opens on fda.gov)

PMK is the FDA product code for Cpr Aid Device Without Feedback, a class I device type, regulated under 21 CFR 870.5210. FDA's definition for this code reads: "A device that performs a simple function such as proper hand placement and/or simple prompting for rate and/or timing of compressions/breathing for the professionally trained rescuer, but offers no feedback related to the quality of the CPR being provided. These devices are intended for use by persons professionally...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PMK
Device name
Cpr Aid Device Without Feedback
FDA definition
A device that performs a simple function such as proper hand placement and/or simple prompting for rate and/or timing of compressions/breathing for the professionally trained rescuer, but offers no feedback related to the quality of the CPR being provided. These devices are intended for use by persons professionally trained in CPR to assure proper use and the delivery of optimal CPR to the victim.
Regulation
21 CFR 870.5210
Device class
Class I
Review panel
Cardiovascular
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code PMK

By decision year
2 clearances under product code PMK with a decision year between 1994 and 1994, 1994 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PMK by decision year
YearClearances
19942

Applicants with the most clearances

Product code PMK
Applicants holding the most 510(k) clearances under product code PMK
ApplicantClearances
Green Field Medical Sourcing, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code