510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K964494Substantially Equivalent

Sleepwizard

Medtronic, Inc., Eden Prairie MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964494 is the FDA 510(k) clearance record for SLEEPWIZARD, a class II device, cleared for Nellcor Puritan Bennett, Inc. on under FDA product code MNR (Ventilatory Effort Recorder). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K964494.

Clearance record

Decision date
Received
(88 days to decision)
Product code
MNR Ventilatory Effort Recorder
Regulation
21 CFR 868.2375
Device class
Class II
Review panel
Anesthesiology
Applicant
Nellcor Puritan Bennett, Inc. 10200 Valley View Rd., Eden Prairie MN
510(k) summary
Summary
Third party review
No

Clearances, product code MNR

Trailing 12 months
6 clearances under product code MNR in the twelve months to November 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MNR, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20261
July 20262
August 20260
September 20261
October 20260
November 20260