VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)

Spirometer, Diagnostic

VITALOGRAPH(IRELAND) LTD.

The following data is part of a premarket notification filed by Vitalograph(ireland) Ltd. with the FDA for Vitalograph Model 4000 (asma-1 And Copd-6).

Pre-market Notification Details

• Device ID: K073155
• 510k Number: K073155
• Device Name: VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)
• Classification: Spirometer, Diagnostic
• Applicant: VITALOGRAPH(IRELAND) LTD. ENNIS INDUSTRIAL ESTATE GORT ROAD Ennis, Co. Clare, IE
• Contact: Tom J Healy
• Correspondent: Tom J Healy; VITALOGRAPH(IRELAND) LTD. ENNIS INDUSTRIAL ESTATE GORT ROAD Ennis, Co. Clare, IE
• Product Code: BZG
• CFR Regulation Number: 868.1840 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-11-08
• Decision Date: 2008-06-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
35099169402769	K073155	000
05099169402515	K073155	000
05099169402508	K073155	000
35099169402493	K073155	000
35099169402486	K073155	000
05099169402478	K073155	000
35099169402462	K073155	000
05099169402447	K073155	000
05099169402430	K073155	000
05099169402423	K073155	000
35099169402417	K073155	000
35099169402400	K073155	000
35099169402394	K073155	000
05099169402539	K073155	000
05099169402546	K073155	000
05099169402744	K073155	000
05099169402690	K073155	000
35099169402684	K073155	000
05099169402669	K073155	000
35099169402646	K073155	000
05099169402638	K073155	000
35099169402622	K073155	000
35099169402615	K073155	000
05099169402607	K073155	000
35099169402592	K073155	000
05099169402577	K073155	000
35099169402561	K073155	000
35099169402387	K073155	000
05099169402379	K073155	000
05099169402362	K073155	000
05099169400382	K073155	000
05099169400375	K073155	000
05099169400368	K073155	000
05099169400351	K073155	000
35099169400345	K073155	000
35099169400338	K073155	000
05099169400320	K073155	000
35099169400314	K073155	000
35099169400048	K073155	000
05099169400030	K073155	000
05099169400009	K073155	000
35099169403797	K073155	000
05099169400399	K073155	000
05099169400603	K073155	000
35099169402356	K073155	000
05099169402348	K073155	000
35099169402332	K073155	000
35099169402325	K073155	000
35099169402318	K073155	000
05099169402300	K073155	000
05099169402058	K073155	000
35099169402035	K073155	000
05099169402027	K073155	000
35099169402011	K073155	000
05099169402003	K073155	000
35099169400659	K073155	000
35099169405555	K073155	000
35099169402783	K073155	000
05099169407978	K073155	000
05099169404601	K073155	000
05099169404595	K073155	000
05099169404533	K073155	000
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05099169404502	K073155	000
05099169404496	K073155	000
35099169404480	K073155	000
05099169404472	K073155	000
05099169404465	K073155	000
05099169404038	K073155	000
05099169404007	K073155	000
05099169403789	K073155	000
05099169404984	K073155	000
05099169404991	K073155	000
05099169407701	K073155	000
05099169407534	K073155	000
05099169407503	K073155	000
35099169407498	K073155	000
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35099169407306	K073155	000
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35099169405500	K073155	000
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35099169405012	K073155	000
05099169405004	K073155	000
05099169403734	K073155	000
05099169403727	K073155	000
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35099169403469	K073155	000
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05099169403031	K073155	000
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35099169402912	K073155	000
35099169402905	K073155	000
35099169402899	K073155	000
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