ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA

Gas-machine, Anesthesia

ACCUTRON, INC.

The following data is part of a premarket notification filed by Accutron, Inc. with the FDA for Analgesia Gas Machine, Model Digital Ultra.

Pre-market Notification Details

• Device ID: K052335
• 510k Number: K052335
• Device Name: ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA
• Classification: Gas-machine, Anesthesia
• Applicant: ACCUTRON, INC. 13605 WEST 7TH AVENUE Golden, CO 80401 -4604
• Contact: Robert N Clark
• Correspondent: Robert N Clark; ACCUTRON, INC. 13605 WEST 7TH AVENUE Golden, CO 80401 -4604
• Product Code: BSZ
• CFR Regulation Number: 868.5160 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-08-26
• Decision Date: 2005-11-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00813830026979	K052335	000
00813830028324	K052335	000
00813830028836	K052335	000
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00813830028393	K052335	000
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00813830028263	K052335	000
00813830028300	K052335	000
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00813830023329	K052335	000
00813830028317	K052335	000
00813830023312	K052335	000
00813830027785	K052335	000
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00813830026993	K052335	000
00813830024586	K052335	000
00813830027426	K052335	000
00813830027709	K052335	000
00813830028195	K052335	000
00813830028522	K052335	000
00813830023305	K052335	000
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00810085200086	K052335	000
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00813830024661	K052335	000
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00813830025224	K052335	000
00813830025330	K052335	000
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00813830023527	K052335	000
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00813830023916	K052335	000
00813830023930	K052335	000
00813830024258	K052335	000
00813830024296	K052335	000
00813830024470	K052335	000
00813830027921	K052335	000