FDA 510(k)

HP ORVUE INTRA-OP (M2510A)

K-Number: K965160 · 1997-09-11

Decision Date1997-09-11

Product CodeBSZ

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

HP ORVUE INTRA-OP (M2510A) is the device name listed in this FDA 510(k) record. The listed applicant is Hewlett-Packard GmbH. It received FDA 510(k) clearance on 1997-09-11 under 510(k) number K965160. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HP ORVUE INTRA-OP (M2510A)?

HP ORVUE INTRA-OP (M2510A) is a medical device that received FDA 510(k) clearance on 1997-09-11. The listed applicant is Hewlett-Packard GmbH. The 510(k) number is K965160.

When did HP ORVUE INTRA-OP (M2510A) receive FDA 510(k) clearance?

HP ORVUE INTRA-OP (M2510A) received FDA 510(k) clearance on 1997-09-11, under 510(k) number K965160.

Who is the listed applicant for HP ORVUE INTRA-OP (M2510A)?

The FDA 510(k) record lists Hewlett-Packard GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HP ORVUE INTRA-OP (M2510A)?

The FDA product code for HP ORVUE INTRA-OP (M2510A) is BSZ.

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Related Devices (Code: BSZ)

K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K252746Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)Drägerwerk AG Co. Kgaa K251352Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)Codonics.Incorporated K230931AtlanDrägerwerk AG Co. Kgaa K213867Carestation 750/750cDatex-Ohmeda, Inc.K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.