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FDA 510(k)

AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608

K-Number: K982518 · 1999-01-14

ApplicantWisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
Decision Date1999-01-14
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608 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 1999-01-14 under 510(k) number K982518. 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 AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608?

AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608 is a medical device that received FDA 510(k) clearance on 1999-01-14. The listed applicant is Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh. The 510(k) number is K982518.

When did AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608 receive FDA 510(k) clearance?

AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608 received FDA 510(k) clearance on 1999-01-14, under 510(k) number K982518.

Who is the listed applicant for AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608?

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 AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608?

The FDA product code for AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608 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, #7050CMFK992513THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMFK990662DISPOSABLE HEATING TUBING SET #7642HSESK982515POWER-DRIVE, WISAP MODEL #7688PD/7688PD1

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Related Devices (Code: HET)

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

View on FDA Database →

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

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