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FDA 510(k)

THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF

K-Number: K992513 · 2000-03-17

ApplicantWisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
Decision Date2000-03-17
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF is the device name listed in this FDA 510(k) record. The listed applicant is Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh. It received FDA 510(k) clearance on 2000-03-17 under 510(k) number K992513. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF?

THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF is a medical device that received FDA 510(k) clearance on 2000-03-17. The listed applicant is Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh. The 510(k) number is K992513.

When did THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF receive FDA 510(k) clearance?

THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF received FDA 510(k) clearance on 2000-03-17, under 510(k) number K992513.

Who is the listed applicant for THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF?

The FDA 510(k) record lists Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF?

The FDA product code for THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF is HET.

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Other records listing Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh as applicant

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.

K031014HI-FLO THERME PNEU 45, WISAP #7083, 7083VK011510MULTI HI-FLO PNEU, WISAP #7080K992481CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMFK990662DISPOSABLE HEATING TUBING SET #7642HSESK982515POWER-DRIVE, WISAP MODEL #7688PD/7688PD1K982518AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608

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Official Source

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