Sapphire

Ventilator, Non-continuous (respirator)

RESPIRONICS INC.

The following data is part of a premarket notification filed by Respironics Inc. with the FDA for Sapphire.

Pre-market Notification Details

• Device ID: K152356
• 510k Number: K152356
• Device Name: Sapphire
• Classification: Ventilator, Non-continuous (respirator)
• Applicant: RESPIRONICS INC. 1001 MURRY RIDGE LANE Murrysville, PA 15668
• Contact: Colleen Witt
• Correspondent: Colleen Witt; RESPIRONICS INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146
• Product Code: BZD
• Subsequent Product Code: CBK
• Subsequent Product Code: MNS
• Subsequent Product Code: MNT
• Subsequent Product Code: NOU
• CFR Regulation Number: 868.5905 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-08-20
• Decision Date: 2016-01-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00606959048164	K152356	000
00606959046818	K152356	000
00606959046801	K152356	000
00606959046795	K152356	000
00606959046788	K152356	000
00606959046771	K152356	000
00606959046764	K152356	000
00606959046757	K152356	000
00606959046740	K152356	000
00606959045248	K152356	000
00606959049956	K152356	000
00606959046825	K152356	000
00606959046979	K152356	000
00606959047426	K152356	000
00606959047952	K152356	000
00606959047549	K152356	000
00606959047532	K152356	000
00606959047525	K152356	000
00606959047518	K152356	000
00606959047501	K152356	000
00606959047495	K152356	000
00606959047488	K152356	000
00606959047471	K152356	000
00606959047464	K152356	000
00606959049949	K152356	000
00606959049932	K152356	000
00606959049109	K152356	000
00606959051362	K152356	000
00606959049840	K152356	000
00606959049093	K152356	000
00606959049086	K152356	000
00606959049079	K152356	000
00606959049062	K152356	000
00606959049055	K152356	000
00606959049048	K152356	000
00606959049031	K152356	000
00606959052093	K152356	000
00606959053519	K152356	000
00606959055919	K152356	000
00606959049918	K152356	000
00606959049901	K152356	000
00606959049895	K152356	000
00606959049888	K152356	000
00606959049864	K152356	000
00606959049857	K152356	000
00606959052215	K152356	000
00606959049963	K152356	000
00606959049925	K152356	000
00606959049871	K152356	000
00606959049024	K152356	000
00606959054790	K152356	000
00606959052246	K152356	000
00606959052239	K152356	000
00606959052222	K152356	000
00606959051355	K152356	000
00606959051348	K152356	000
00606959051331	K152356	000
00606959051324	K152356	000
00606959051317	K152356	000
00606959051300	K152356	000
00606959051294	K152356	000
00606959052253	K152356	000
00606959052420	K152356	000
00606959052437	K152356	000
00606959053984	K152356	000
00606959053922	K152356	000
00606959053533	K152356	000
00606959052871	K152356	000
30606959052834	K152356	000
00606959052499	K152356	000
00606959052482	K152356	000
00606959052468	K152356	000
00606959052451	K152356	000
00606959052444	K152356	000
00606959051287	K152356	000
00606959051270	K152356	000
00606959049345	K152356	000
00606959048904	K152356	000
00606959048584	K152356	000
00606959048577	K152356	000
00606959048560	K152356	000
00606959048553	K152356	000
00606959048546	K152356	000
00606959048539	K152356	000
00606959048522	K152356	000
00606959048515	K152356	000
00606959049727	K152356	000
00606959050013	K152356	000
00606959050020	K152356	000
00606959051263	K152356	000
00606959051256	K152356	000
00606959050730	K152356	000
00606959050723	K152356	000
00606959050716	K152356	000
00606959050709	K152356	000
00606959050693	K152356	000
00606959050051	K152356	000
00606959050044	K152356	000
00606959050037	K152356	000
00606959048508	K152356	000