510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K893713Substantially Equivalent

Nova Oxygen Tent

Nova Health Systems, Inc., Blackwood NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893713 is the FDA 510(k) clearance record for NOVA OXYGEN TENT, a class I device, cleared for Nova Health Systems, Inc. on under FDA product code BYL (Tent, Oxygen). FDA records list 3 510(k) clearances for Nova Health Systems, Inc., from to . As of , FDA records show no recalls naming K893713.

Clearance record

Decision date
Received
(95 days to decision)
Product code
BYL Tent, Oxygen
Regulation
21 CFR 868.5700
Device class
Class I
Review panel
Anesthesiology
Applicant
Nova Health Systems, Inc. 1001 Lower Landing Rd., Blackwood NJ
Third party review
No

Clearances, product code BYL

Trailing 12 months

FDA records hold no clearances under product code BYL in the trailing twelve months.

FDA records show no clearances under product code BYL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BYL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260