ALTERA NEBULIZER SYSTEM, MODEL 678G1002

Nebulizer (direct Patient Interface)

PARI RESPIRATORY EQUIPMENT, INC.

The following data is part of a premarket notification filed by Pari Respiratory Equipment, Inc. with the FDA for Altera Nebulizer System, Model 678g1002.

Pre-market Notification Details

• Device ID: K100380
• 510k Number: K100380
• Device Name: ALTERA NEBULIZER SYSTEM, MODEL 678G1002
• Classification: Nebulizer (direct Patient Interface)
• Applicant: PARI RESPIRATORY EQUIPMENT, INC. 2943 OAKLAKE BLVD. Midlothian, VA 23112
• Contact: James L Mcintire
• Correspondent: James L Mcintire; PARI RESPIRATORY EQUIPMENT, INC. 2943 OAKLAKE BLVD. Midlothian, VA 23112
• Product Code: CAF
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2010-02-16
• Decision Date: 2010-02-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00744229789024	K100380	000
00744229678229	K100380	000
00744229678090	K100380	000
00744229678311	K100380	000
00744229678304	K100380	000
00744229178026	K100380	000