SIMPLE T NASAL MASK

Ventilator, Non-continuous (respirator)

RESPIRONICS, INC.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Simple T Nasal Mask.

Pre-market Notification Details

• Device ID: K121631
• 510k Number: K121631
• Device Name: SIMPLE T NASAL MASK
• Classification: Ventilator, Non-continuous (respirator)
• Applicant: RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668
• Contact: Michelle Brinker
• Correspondent: Michelle Brinker; RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668
• Product Code: BZD
• CFR Regulation Number: 868.5905 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-06-04
• Decision Date: 2012-10-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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00606959040021	K121631	000
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