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FDA 510(k)

AUTODELFIA NEONATAL HTSH L KIT (B077-112)

K-Number: K973276 · 1997-11-20

ApplicantEg &G Wallac
Decision Date1997-11-20
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTODELFIA NEONATAL HTSH L KIT (B077-112) is the device name listed in this FDA 510(k) record. The listed applicant is Eg &G Wallac. It received FDA 510(k) clearance on 1997-11-20 under 510(k) number K973276. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTODELFIA NEONATAL HTSH L KIT (B077-112)?

AUTODELFIA NEONATAL HTSH L KIT (B077-112) is a medical device that received FDA 510(k) clearance on 1997-11-20. The listed applicant is Eg &G Wallac. The 510(k) number is K973276.

When did AUTODELFIA NEONATAL HTSH L KIT (B077-112) receive FDA 510(k) clearance?

AUTODELFIA NEONATAL HTSH L KIT (B077-112) received FDA 510(k) clearance on 1997-11-20, under 510(k) number K973276.

Who is the listed applicant for AUTODELFIA NEONATAL HTSH L KIT (B077-112)?

The FDA 510(k) record lists Eg &G Wallac as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTODELFIA NEONATAL HTSH L KIT (B077-112)?

The FDA product code for AUTODELFIA NEONATAL HTSH L KIT (B077-112) is JLW.

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Related Devices (Code: JLW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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