SURFACE SKIN TEMP PROBE W/THERMOCOUPLE TYPE T

Thermometer, Electronic, Clinical

RESPIRATORY SUPPORT PRODUCTS, INC.

The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Surface Skin Temp Probe W/thermocouple Type T.

Pre-market Notification Details

• Device ID: K864195
• 510k Number: K864195
• Device Name: SURFACE SKIN TEMP PROBE W/THERMOCOUPLE TYPE T
• Classification: Thermometer, Electronic, Clinical
• Applicant: RESPIRATORY SUPPORT PRODUCTS, INC. 3183-D AIRWAY AVE. Costa Mesa, CA 92626
• Contact: Anthony V Beran
• Correspondent: Anthony V Beran; RESPIRATORY SUPPORT PRODUCTS, INC. 3183-D AIRWAY AVE. Costa Mesa, CA 92626
• Product Code: FLL
• CFR Regulation Number: 880.2910 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-10-27
• Decision Date: 1986-11-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10695085000211	K864195	000
10695085000112	K864195	000
10695085000129	K864195	000
20695085000133	K864195	000
10695085000143	K864195	000
20695085000157	K864195	000
20695085000164	K864195	000
10695085000174	K864195	000
10695085000181	K864195	000
20695085000195	K864195	000
20695085000201	K864195	000
20695085000102	K864195	000